Cleared Traditional

K915870 - OPUS RUBELLA TEST SYSTEM

K915870 is an FDA 510(k) clearance for OPUS RUBELLA TEST SYSTEM, manufactured by Pb Diagnostics, Inc.. The device is a Class 2 Pathology device with product code LFX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K915870 · Pb Diagnostics, Inc. · Pathology device
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Mar 1992
Decision
83d
Days
Class 2
Risk

K915870 is an FDA 510(k) clearance for the OPUS RUBELLA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Pb Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on March 23, 1992 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.3510 - the FDA pathology 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 Diagnostics, Inc. devices

FDA 510(k) Submission Details - K915870

510(k) Number K915870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1991
Decision Date March 23, 1992
Days to Decision 83 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 77d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFX Device Classification - Class 2, Special Controls

Product Code LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
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 Pathology devices follow this clearance model.

Regulatory Peers - LFX Enzyme Linked Immunoabsorbent Assay, Rubella

All 64
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K915870.
BARTELS RUBELLA IGM EIA
K922581 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS RUBELLA IGG EIA
K922586 · Baxter Diagnostics, Inc. · Sep 1992
RUBELLA IGM ELISA TEST SYSTEM
K914028 · Zeus Scientific, Inc. · Apr 1992
RUBELLA IGG ELISA TEST
K915893 · Gull Laboratories, Inc. · Mar 1992
ELISA RUBELLA IGM
K914420 · Sclavo, Inc. · Dec 1991
RUBENOSTIKA IGG MICROELISA SYSTEM
K911393 · Organon Teknika Corp. · Apr 1991