Cleared Traditional

K954732 - ACCESS TOTAL BHCG ASSAY (MODIFICATION)

K954732 is the FDA 510(k) clearance for ACCESS TOTAL BHCG ASSAY (MODIFICATION) by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K954732 · Bio-Rad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
49d
Days
Class 2
Risk

K954732 is an FDA 510(k) clearance for the ACCESS TOTAL BHCG ASSAY (MODIFICATION). Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K954732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date November 20, 1995
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 158
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K954732.
SAS ONE-STEP PREGNANCY
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K954029 · Abbott Laboratories · Oct 1995
RAPIDVUE(TM) HCG
K945969 · Quidel Corp. · Jan 1995