B-Clone HCG Assay

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K831155 ↗

FDA Product Code

JHJ

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Model Ucg Assay

  Class II

  FDA 510(k) K822520 Active Cleared 28 Sep 1982

• Ovu Stick Urine Hlh Kit

  Class I

  FDA 510(k) K840412 Active Cleared 13 Apr 1984

• Plus Urine Hcg Assay

  Class II

  FDA 510(k) K840738 Active Cleared 19 Apr 1984

• Ovustick Self-Test

  Class I

  FDA 510(k) K843284 Active Cleared 11 Dec 1984

• Ramp Herpes Simplex Virus (Hsv) (Cct)

  Class II

  FDA 510(k) K874863 Active Cleared 16 Feb 1988

• Pregnastick Urine Hcg Kit

  Class II

  FDA 510(k) K833504 Active Cleared 9 Jan 1984

See all devices from Monoclonal Antibodies, Inc. →

• What clinical specialty is this device primarily intended for, and how does it function in that setting?

  The B-Clone HCG Assay is designed for use in clinical chemistry laboratories, where it serves as a qualitative diagnostic tool for detecting human chorionic gonadotropin (hCG) in human samples. It employs an agglutination method with monoclonal antibodies to identify hCG, a biomarker used to confirm pregnancy or monitor related conditions. This makes it particularly relevant for obstetrics, fertility clinics, or any setting where pregnancy testing is performed.

• Is this device single-use, and if so, what does that mean for workflow and sample handling?

  Yes, the B-Clone HCG Assay is supplied as a single-use diagnostic reagent, meaning each test kit is intended for one use only. This design ensures consistency and reliability in results while minimizing cross-contamination risks. Clinicians should prepare a new test for each sample, adhering to standard laboratory practices for in vitro diagnostics to avoid carryover or degradation of reagents.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its safety and equivalence?

  The B-Clone HCG Assay received FDA 510(k) clearance (K831155) under the Traditional 510(k) pathway, demonstrating it is *substantially equivalent* to a predicate device already on the market. This means the FDA reviewed its design, performance, and safety data to confirm it meets the same intended use and risk profile as the predecessor, ensuring comparable diagnostic accuracy and reliability for detecting hCG in clinical settings.

• Are there specific storage requirements mentioned for this assay, or should it follow general lab practices?

  The regulatory data does not specify unique storage conditions beyond standard laboratory practices for in vitro diagnostics. As a single-use reagent, it should be stored in a way that maintains its integrity—typically at room temperature or as indicated on the packaging—until use. Clinicians should follow the manufacturer’s instructions (if provided) or local protocols to ensure optimal performance and shelf life.