Product Overview
The CLA-1™ Luminometer is a compact chemiluminescence reader designed to complete the manual OPTIGEN® allergen-specific IgE assay workflow. After an OPTIGEN pette has been processed according to the assay instructions, the CLA-1 measures the light signal produced by allergen-specific IgE bound within the pette.
The system can analyze up to 180 allergens in approximately eight minutes and automatically prints a report identifying the allergens tested and the severity class of the patient’s response. A self-diagnostic check is performed each time the instrument is powered on, with system status shown on the digital display.
The CLA-1 is the reader for processed OPTIGEN pettes; it does not automate the assay-preparation steps. Laboratories seeking sample-to-result automation should review the OPTIGEN AP3600 Automated Allergy Diagnostic System.
Up to 180 Allergens
Reads multiple processed OPTIGEN pettes in one analysis cycle.
Approximately 8 Minutes
Provides rapid reading of prepared allergen-specific IgE assay panels.
Automatic Printed Report
Lists tested allergens and the reported severity class for each response.
CLA-1 Allergy-Testing Workflow
1. Process the Assay
Prepare the human serum sample and process the compatible OPTIGEN pette according to the current assay instructions.
2. Load Processed Pettes
Place the completed pette panels into the CLA-1 reader using the required cassette and instrument procedure.
3. Read and Report
The CLA-1 measures the chemiluminescent signal and automatically prints the allergen-specific result report.
All assay preparation, quality-control and interpretation requirements must follow the current OPTIGEN instructions for use and the laboratory’s established procedures.
Key Features
- Reads processed OPTIGEN allergen-specific IgE pette panels
- Chemiluminescence detection of the signal generated by the OPTIGEN assay
- Analyzes up to 180 allergens in approximately eight minutes
- Automatically prints a report listing tested allergens and response severity
- Performs a self-diagnostic check each time the instrument is powered on
- Displays instrument status on a digital screen
- Compact reader designed for professional clinical laboratory use
- Supports preconfigured OPTIGEN inhalant, food, mixed and environmental panels designated for the CLA-1
Product Specifications
| Jant Catalog Number | HCD95013 |
|---|---|
| Product | CLA-1™ Luminometer |
| Instrument Type | Chemiluminescence luminometer for processed OPTIGEN pette panels |
| Compatible Assay | OPTIGEN® Allergen-Specific IgE Assay using panels designated for the CLA-1 |
| Workflow | Reads pettes after completion of the manual OPTIGEN assay process |
| Reading Capacity | Up to 180 allergens |
| Reading Time | Approximately eight minutes |
| Detection | Chemiluminescence |
| Output | Automatically printed report listing tested allergens and response severity |
| System Check | Self-diagnostic check at power-up with status displayed on the digital screen |
| Result Type | Semiquantitative allergen-specific IgE result classes according to the applicable assay labeling |
| Unit of Measurement | Each |
OPTIGEN Panels Listed for the CLA-1
The manufacturer currently lists the following OPTIGEN panel configurations for use with the CLA-1 Luminometer:
Inhalant Panels
- OPTIGEN Inhalant US 36
- OPTIGEN Environmental 36
Food Panels
- OPTIGEN Food US 20
- OPTIGEN Food 29
Mixed Panel
- OPTIGEN Mix US 36
Review Jant’s OPTIGEN Allergen-Specific IgE Assay page and contact Jant Pharmacal to confirm the current panel menu, item numbers, package sizes and availability.
CLA-1 or AP3600?
CLA-1 Luminometer
- Reads processed OPTIGEN pettes
- Used with the manual OPTIGEN assay workflow
- Analyzes up to 180 allergens in approximately eight minutes
- Compact option for laboratories that do not require sample-to-result automation
OPTIGEN AP3600
- Fully automates the OPTIGEN assay from sample tube through result
- Processes up to 50 pettes per run
- Supports up to 100 panels per day
- Designed for laboratories seeking higher-throughput, walk-away automation
Jant Pharmacal can help evaluate the appropriate allergy-testing platform and prepare a complimentary ROI proposal.
Allergy Assays and Laboratory Support
Connect the CLA-1 with the compatible OPTIGEN assays and broader allergy-testing resources available through Jant Pharmacal.
View OPTIGEN Assays and Panels Compare the OPTIGEN AP3600 Browse Allergy Diagnostics Request an ROI ProposalImportant Product Information
- The CLA-1 is designed to read processed OPTIGEN allergen-specific IgE assay pettes and does not automate the assay-preparation steps.
- The OPTIGEN assay is an in vitro diagnostic test for prescription use in professional clinical laboratories.
- Results are intended to aid in the diagnosis of IgE-mediated allergic disorders and must be evaluated with the patient’s clinical history and other relevant findings.
- Use only OPTIGEN panels and accessories designated for the CLA-1 and follow the current instrument and assay instructions.
- Confirm the exact instrument configuration, included accessories, installation requirements, training, warranty and service coverage before ordering.
- Panel availability, item numbers, package sizes and specifications may change; verify current information with Jant Pharmacal.
Documentation and Resources
Review the OPTIGEN assay resources and manufacturer information. Contact Jant Pharmacal for the current CLA-1 operator documentation, OPTIGEN instructions for use and safety documentation applicable to the selected system and panels.
FDA OPTIGEN 510(k) Decision Summary OPTIGEN Assays and Allergen Menu Manufacturer CLA-1 Product PageFrequently Asked Questions
The CLA-1 is a compact chemiluminescence reader used to measure the signal from processed OPTIGEN allergen-specific IgE assay pettes.
No. The CLA-1 completes the manual OPTIGEN assay workflow by reading the processed pettes. The assay-preparation and processing steps are performed before the pettes are loaded into the reader.
The CLA-1 can analyze up to 180 allergens in approximately eight minutes.
The CLA-1 automatically prints a report listing the allergens tested and the reported severity class of the patient’s allergen-specific IgE response.
Yes. The instrument performs a self-diagnostic check each time it is powered on and displays its status on the digital screen.
The CLA-1 is used with compatible OPTIGEN Allergen-Specific IgE Assay panels. The manufacturer currently lists Inhalant US 36, Food US 20, Mix US 36, Environmental 36 and Food 29 configurations for the CLA-1. Confirm current availability with Jant Pharmacal.
The OPTIGEN assay uses human serum. Follow the current assay instructions for specimen collection, preparation, storage and handling requirements.
The CLA-1 reads pettes after the manual OPTIGEN assay steps have been completed. The AP3600 automates the OPTIGEN workflow from sample tube through result and is designed for higher-throughput testing.
No. OPTIGEN results are intended to aid in the clinical diagnosis of IgE-mediated allergic disorders and must be evaluated with the patient’s clinical history and other relevant findings.
Yes. Jant Pharmacal can help review testing volume, workflow, compatible panels, controls and consumables and can prepare a complimentary ROI proposal.
Ordering Information
To request availability, product configuration or a quote, call Jant Pharmacal at 800.676.5565
| Catalog Number | Description | Unit of Measurement |
|---|---|---|
| HCD95013 | CLA-1™ Luminometer – Specific IgE Assay Reader | Each |
Compatible OPTIGEN panels, controls and assay materials are ordered separately. Please confirm the complete configuration, included accessories, installation requirements, training, warranty and service coverage when requesting a quote.