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Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1 and Apob Performance Verifiers

by Ortho-Clinical Diagnostics, Inc.

510(k) K042521

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042521 Date18 Nov 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JIT
Device Class
Class II
Regulation
21 CFR Part 862.1150
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

VITROS Chemistry Products ApoA1 and ApoB reagents, calibrator kits 21 and 22, and ApoA1 and ApoB performance verifiers are liquid-based assays for use on the VITROS 5,1 FS Chemistry System, an automated clinical chemistry analyzer. The system combines reagents with human serum or plasma samples to perform immunoturbidimetric assays for the measurement of apolipoprotein A1 and apolipoprotein B.

These devices are supplied as reagent and calibrator kits for in vitro diagnostic use in clinical laboratory settings. They are intended for use with the VITROS 5,1 FS Chemistry System and are authorized under FDA 510(k) clearance K042521 with product code JIT and regulation number 862.1150. The device is classified as a Class II medical device and is non-returnable, with delivery typically within 7-10 days when shipped directly from the manufacturer.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the VITROS Chemistry Products ApoA1 and ApoB reagents and calibrator kits?

    The VITROS Chemistry Products ApoA1 and ApoB reagents and calibrator kits 21 and 22 are intended for use with the VITROS 5,1 FS Chemistry System to perform immunoturbidimetric assays for the measurement of apolipoprotein A1 and apolipoprotein B in human serum or plasma samples in clinical laboratory settings.

  • Are the VITROS ApoA1 and ApoB reagents and calibrator kits supplied as liquid-based assays?

    Yes, the VITROS Chemistry Products ApoA1 and ApoB reagents, calibrator kits 21 and 22, and ApoA1 and ApoB performance verifiers are supplied as liquid-based assays, which are designed to be combined with human serum or plasma samples on the VITROS 5,1 FS Chemistry System for automated measurement.

  • What regulatory authorization does the VITROS ApoA1 and ApoB device have?

    The device is authorized under FDA 510(k) clearance K042521 with product code JIT and regulation number 862.1150, and is classified as a Class II medical device.