Cleared Traditional

K821657 - RIAGEN B-HCG RIA

K821657 is the FDA 510(k) clearance for RIAGEN B-HCG RIA by Biogenex Laboratories. It is a Class 2 Immunology device (product code JHI) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K821657 · Biogenex Laboratories · Immunology device
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Jul 1982
Decision
39d
Days
Class 2
Risk

K821657 is an FDA 510(k) clearance for the RIAGEN B-HCG RIA. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Biogenex Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1155 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biogenex Laboratories devices

Submission Details

510(k) Number K821657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1982
Decision Date July 13, 1982
Days to Decision 39 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 104d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K821657.
GENESIS B-HCG
K823753 · Armkel, LLC · Jan 1983
B-HCG
K822343 · Diagnostic Products Corp. · Sep 1982
TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT
K821944 · Hybritech, Inc. · Jul 1982
ROCHE(R) B-HCG RIA URINE STANDARD
K820942 · Hoffmann-La Roche, Inc. · May 1982
AMERLEX B-LCG RIA KIT
K821031 · Amersham Corp. · May 1982
TANDEM HCG KIT
K820822 · Hybritech, Inc. · Apr 1982