Cardio Rep Ck Calibrators 1 & 2 Cat. No. 3322 & 3323
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K932768 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 Cardio Rep CK Calibrators 1 & 2 are multi-analyte calibrators designed for use in clinical chemistry systems. These calibrators provide standardized reference values for creatine kinase (CK) and other analytes, ensuring accurate and consistent measurement performance in laboratory testing.
These calibrators are supplied as liquid mixtures for in vitro diagnostic use and are intended for single-use applications. They are classified under product code JIX and have received FDA 510(k) clearance (K932768) as substantially equivalent to a predicate device. Storage conditions and regulatory compliance are governed by FDA regulation 862.1150, with no indication of MRI safety or reusable design.
Frequently asked questions
What is the primary purpose of the Cardio Rep CK Calibrators 1 & 2?
The Cardio Rep CK Calibrators 1 & 2 are designed to provide standardized reference values for creatine kinase (CK) and other analytes in clinical chemistry systems. They ensure accurate and consistent measurement performance in laboratory testing, helping to maintain precision across different tests.
Are these calibrators intended for single-use or repeated use?
These calibrators are explicitly intended for single-use applications only. They are supplied as liquid mixtures for in vitro diagnostic use, meaning each vial should be used once and then discarded to maintain accuracy and prevent contamination.
What regulatory pathway was followed for FDA clearance of these calibrators?
The Cardio Rep CK Calibrators 1 & 2 received FDA 510(k) clearance (K932768) under the Traditional 510(k) Review pathway. They were determined to be substantially equivalent to a predicate device, with the review conducted by the Clinical Chemistry (CH) Advisory Committee. The clearance was granted in 1993.
How should these calibrators be stored, and what storage conditions apply?
While the exact storage conditions are not detailed in the provided data, the calibrators are governed by FDA regulation 862.1150, which typically requires adherence to manufacturer-recommended storage (e.g., refrigeration, protection from light, and proper sealing). Always follow the instructions provided with the product to ensure stability and validity.
Are these calibrators compatible with all clinical chemistry systems, or are there specific limitations?
The Cardio Rep CK Calibrators 1 & 2 are multi-analyte calibrators designed for use in clinical chemistry systems, but compatibility depends on the specific system’s requirements. While the data does not list exclusions, it’s critical to verify compatibility with your laboratory’s equipment and follow the manufacturer’s guidelines to ensure accurate results.
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: Cardio Rep Ck Calibrators 1 & 2 Cat. No. 3322 & 3323, K932768 - Cardio Rep Ck Calibrators 1 & 2 Cat. No..., Product List | Helena Laboratories - Innovations for Science & Clinical ..., K932623 FDA 510(k) - QUANTIMETRIX BLOOD GLUCOSE CONTROLS
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K932768 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K932768 24 fields · synced Oct 6, 2026