Cleared Traditional

K901935 - OPUS (TM) HCG

K901935 is the FDA 510(k) clearance for OPUS (TM) HCG by Pb Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code JHI) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K901935 · Pb Diagnostic Systems, Inc. · Toxicology device
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Jun 1990
Decision
57d
Days
Class 2
Risk

K901935 is an FDA 510(k) clearance for the OPUS (TM) HCG. 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 June 26, 1990 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1155 - the FDA toxicology 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K901935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date June 26, 1990
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 87d · 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 Toxicology 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 K901935.
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219 · Abbott Laboratories · Sep 1990
AFFINITY HCG TEST SYSTEM
K902720 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
KODAK SURECELL(TM) HCG-URINE TEST KIT
K902136 · Eastman Kodak Company · Jun 1990
IMX HCG (LIST #03A63)
K900327 · Abbott Laboratories · Apr 1990
HCG SOLID PHASE COMPONENT SYSTEM
K901045 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT
K896587 · Medix Biotech, Inc. · Feb 1990