Chromopep PC, Chromopep AT, Models 2.5 and 5
FDA 510(k)Class II (US FDA 510(k))
by Horiba Abx
Identifiers
- 510(k) Number
- K050448 FDA 510(k)
- FDA Product Code
- GGP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7290 FDA 510(k)
- Regulation Number
- 864.7290 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Chromopep PC and Chromopep AT are chromogenic assays designed for the qualitative and quantitative measurement of Protein C and Antithrombin deficiencies, respectively. These devices fall under the classification of Test, Qualitative And Quantitative Factor Deficiency (product code GGP) and are intended for use in hematology diagnostics. They employ chromogenic substrate technology to detect and quantify specific coagulation factors in plasma samples, aiding in the diagnosis of hereditary or acquired deficiencies.
These assays are supplied as single-use reagents for in vitro diagnostic use in clinical laboratories. They are regulated under FDA 510(k) clearance (K050448) and classified as Class II devices under Special Controls (Regulation 864.7290). The models 2.5 and 5 refer to the reagent kit sizes, with no indication of sterility or MRI safety requirements. Storage conditions and shelf life are not specified in the provided data, but compliance with standard laboratory practices for reagent storage is implied.
Frequently asked questions
What specific coagulation factors do the Chromopep PC and Chromopep AT assays measure, and how are they used in clinical practice?
The Chromopep PC assay measures Protein C deficiencies, while the Chromopep AT assay quantifies Antithrombin deficiencies. Both utilize chromogenic substrate technology to detect and quantify these coagulation factors in plasma samples, helping clinicians diagnose hereditary or acquired deficiencies that may contribute to bleeding or thrombotic disorders. These assays are designed for use in hematology diagnostics within clinical laboratories.
Are the Chromopep PC and Chromopep AT assays single-use or reusable, and how are they supplied?
The Chromopep PC and Chromopep AT assays are supplied as single-use reagents for in vitro diagnostic use. Each kit is intended for one-time use per test, ensuring consistency and reducing the risk of contamination in laboratory settings.
What are the available sizes for the Chromopep PC and Chromopep AT reagent kits, and how do they differ?
The Chromopep PC and Chromopep AT assays come in two model sizes: 2.5 and 5. These numbers likely refer to the reagent kit sizes, indicating the quantity of tests or reagents included in each kit. The 2.5 model may be suitable for smaller-scale testing, while the 5 model offers a larger volume for higher throughput in clinical laboratories.
How should the Chromopep PC and Chromopep AT assays be stored, and what is their expected shelf life?
The provided data does not specify exact storage conditions or shelf life for the Chromopep PC and Chromopep AT assays. However, compliance with standard laboratory practices for reagent storage is implied. Laboratories should follow manufacturer guidelines (available in the accompanying documentation) to ensure optimal performance, typically involving refrigeration or room-temperature storage as appropriate for chromogenic assays.
What regulatory pathway was followed for FDA clearance of the Chromopep PC and Chromopep AT assays, and what classification do they hold?
The Chromopep PC and Chromopep AT assays were cleared through the FDA’s 510(k) pathway under the classification of Class II devices, specifically under Special Controls (Regulation 864.7290). They fall under the product code GGP (Test, Qualitative And Quantitative Factor Deficiency) and were reviewed by the Hematology (HE) Advisory Committee. The clearance type was Traditional, and the decision was made in 2005 with the determination of Substantial Equivalence (SESE).
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: Chromopep Pc, Chromopep At, Models 2.5 and 5, K050448 FDA 510 (k) - CHROMOPEP PC | Horiba Abx, CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 510(k) K050448 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050448 | Class II | Active |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA 510(k) K050448 24 fields · synced Sep 20, 2026