Cleared Traditional

K932279 - OPUS TOTAL B-HCG TEST SYSTEM

K932279 is the FDA 510(k) clearance for OPUS TOTAL B-HCG TEST SYSTEM by Pb Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K932279 · Pb Diagnostic Systems, Inc. · Chemistry device
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Jul 1993
Decision
57d
Days
Class 2
Risk

K932279 is an FDA 510(k) clearance for the OPUS(R) TOTAL B-HCG TEST SYSTEM. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 57 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K932279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1993
Decision Date July 08, 1993
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
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 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K932279.
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