Vitros Immunodiagnostics Total B-HCG Reagent Pack (GEM.1075), Total B-HCG Calibrators (GEM.C075)

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Vitros Immunodiagnostics Products Total B-Hcg Reagent Pack (GEM.1075), Total B-Hcg Calibrators (GEM.C075)

510(k) Number

K970894 ↗

FDA Product Code

DHA

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Vitros Immunodiagnostics Products/Ck-Mb Reagent Pack(GEM.1300)/Ck-Mb Calibrators (GEM.C300)

  Class I

  FDA 510(k) K973030 Active Cleared 4 Sep 1997

• Vitros Immunodiagnostics Products Lh Reagent Pack (GEM.1055) and Lh Calibrators (GEM.CO55) Open recall

  Class I

  FDA 510(k) K964982 Active Cleared 20 Feb 1997

• Ektachem Dt Ldl Cholesterol Kit

  Class I

  FDA 510(k) K955904 Active Cleared 24 May 1996

• Vitros Immunodiagnostic Products Range Verifiers

  Class I

  FDA 510(k) K973517 Active Cleared 25 Sep 1997

• Vitros Immunodiagnostics Products Free T4 Reagent Pack (GEM.1015) Free T4 Calibrators (GEM.CO15)

  Class II

  FDA 510(k) K965142 Active Cleared 18 Mar 1997

• Ektachem Clinical Chemistry Calcium (Ca) Slide

  Class II

  FDA 510(k) K961226 Active Cleared 7 May 1996

See all devices from Johnson & Johnson Clinical Diagnostics, Inc. →

• What is the Vitros Total B-HCG Reagent Pack (GEM.1075) used for?

  The Vitros Total B-HCG Reagent Pack (GEM.1075) is designed for the qualitative and quantitative detection of total human chorionic gonadotropin (HCG) in clinical specimens. This includes intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits. It is part of the Vitros Immunodiagnostics platform, enabling precise diagnostic testing for pregnancy and related conditions in clinical chemistry laboratories.

• How is the Vitros Total B-HCG Reagent Pack (GEM.1075) supplied, and what are its usage instructions?

  The reagent pack (GEM.1075) and calibrators (GEM.C075) are components of the Vitros Immunodiagnostics system and are supplied as part of a diagnostic kit. They are intended for single-use only. The reagents require proper storage under controlled conditions to maintain stability, as outlined in the manufacturer’s instructions. The system uses a chemiluminescent immunoassay method for accurate measurement.

• Are the Vitros Total B-HCG Reagent Pack and Calibrators reusable?

  No, the Vitros Total B-HCG Reagent Pack (GEM.1075) and Total B-HCG Calibrators (GEM.C075) are designed for single-use only. Reusing these components could compromise diagnostic accuracy and compromise sterility or performance, as they are intended to be used once per test cycle within the Vitros Immunodiagnostics platform.

• What storage conditions are required for the Vitros Total B-HCG Reagent Pack?

  The reagent pack and calibrators must be stored under controlled conditions to ensure stability and accuracy. While the exact storage specifications are detailed in the manufacturer’s instructions, typical requirements for such diagnostic reagents include protection from extreme temperatures, light exposure, and humidity. Always refer to the provided documentation for precise storage guidelines.

• What regulatory approval does the Vitros Total B-HCG Reagent Pack hold?

  The Vitros Total B-HCG Reagent Pack (GEM.1075) and Total B-HCG Calibrators (GEM.C075) have received FDA 510K clearance under the Clinical Chemistry advisory committee. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device under the DHA product code.