Cleared Traditional

K921523 - OPUS TOXO-G TEST SYSTEM

K921523 is an FDA 510(k) clearance for OPUS TOXO-G TEST SYSTEM, manufactured by Pb Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K921523 · Pb Diagnostics, Inc. · Microbiology device
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Sep 1992
Decision
167d
Days
Class 2
Risk

K921523 is an FDA 510(k) clearance for the OPUS(R) TOXO-G TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Pb Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on September 14, 1992 after a review of 167 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pb Diagnostics, Inc. devices

FDA 510(k) Submission Details - K921523

510(k) Number K921523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1992
Decision Date September 14, 1992
Days to Decision 167 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 102d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGD Device Classification - Class 2, Special Controls

Product Code LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
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 Microbiology devices follow this clearance model.

Regulatory Peers - LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 82
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K921523.
VIDAS TOXO COMPETITION (TXC) ASSAY
K931334 · Biomerieux Vitek, Inc. · Jun 1993
VIDAS TOXO IG6 ASSAY (TX6)
K922737 · Biomerieux Vitek, Inc. · May 1993
VIDAS TOXOPLASMA GONDII IGM ASSSAY
K923166 · Biomerieux Vitek, Inc. · Feb 1993
BARTELS TOXOPLASMA IGM EIA
K922579 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS TOXOPLASMA IGG EIA
K922585 · Baxter Diagnostics, Inc. · Sep 1992
ENZYGNOST(R) TOXOPLASMOSIS/IGG
K913731 · Behring Diagnostics, Inc. · Apr 1992