K-Assay Apo A1/B Calibrator Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K993606 FDA 510(k)
- FDA Product Code
- JIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1150 FDA 510(k)
- Regulation Number
- 862.1150 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The K-Assay Apo A1/B Calibrator Set is a multi-analyte mixture classified as a calibrator for clinical chemistry applications. It provides standardized reference materials containing known concentrations of apolipoprotein A1 and apolipoprotein B, essential for accurate assay calibration in immunoturbidimetric testing. Designed to support quantitative measurements in laboratory diagnostics, this device ensures consistency and reliability in lipid profile assessments.
Supplied as liquid, ready-to-use calibrators, the set is intended for use in clinical laboratory settings by trained personnel. Each calibrator must be stored at 2–8°C; once reconstituted and diluted, it remains stable for up to two weeks under refrigeration. The device is classified as a Class II medical device under FDA regulations (21 CFR 862.1150) and holds a 510(k) clearance (K993606) for substantial equivalence in clinical chemistry applications. No MRI safety or reusable design specifications are indicated.
Frequently asked questions
What is the K-Assay Apo A1/B Calibrator Set used for?
The K-Assay Apo A1/B Calibrator Set is designed as a standardized reference material for clinical chemistry laboratories. It provides known concentrations of apolipoprotein A1 and apolipoprotein B to calibrate immunoturbidimetric assays. This ensures accurate and consistent quantitative measurements in lipid profile assessments, which are critical for diagnosing cardiovascular risks and monitoring lipid-related conditions.
How is the K-Assay Apo A1/B Calibrator Set supplied and stored?
The calibrator set is supplied as liquid, ready-to-use solutions. Each component must be stored at 2–8°C to maintain stability. Once reconstituted or diluted (if applicable), the calibrators remain stable for up to two weeks when kept refrigerated. Proper storage conditions are essential to preserve the accuracy of the reference materials.
Is the K-Assay Apo A1/B Calibrator Set single-use or reusable?
The K-Assay Apo A1/B Calibrator Set is intended for single-use in clinical laboratory settings. While the packaging may contain multiple calibrator vials, each vial is designed for one calibration procedure. This prevents cross-contamination and ensures the integrity of assay results. Discard any unused portions after opening.
What regulatory clearance does the K-Assay Apo A1/B Calibrator Set hold?
The K-Assay Apo A1/B Calibrator Set holds a 510(k) clearance (K993606) from the FDA, demonstrating substantial equivalence in clinical chemistry applications. It is classified as a Class II medical device under 21 CFR 862.1150. This clearance confirms that the device meets regulatory standards for safety and performance in immunoturbidimetric testing for apolipoprotein assays.
Are there different models or sizes available for the K-Assay Apo A1/B Calibrator Set?
The provided device data does not specify multiple models or sizes for the K-Assay Apo A1/B Calibrator Set. It is described as a multi-analyte mixture calibrator set, intended for standardized calibration of apolipoprotein A1 and B assays. If additional variants exist, they would likely be differentiated by specific lot sizes or additional components, but no such details are included in the available information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Kamiya Biomedical Company - Clinical Diagnostics - Apo AI / B Calibrator, K-ASSAY APO A1/B CALIBRATOR SET - fda.innolitics.com, Kamiya Biomedical Company - Clinical Diagnostics - Apo AI ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993606 | Class II | Active |
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Manufacturer
- Manufacturer
- Kamiya Biomedical Co.
Sources (1)
- FDA 510(k) K993606 24 fields · synced Oct 5, 2026