Cleared Traditional

K951495 - ACCESS TOXO IGG ASSAY ON THE ACCESS IMM...

K951495 is the FDA 510(k) clearance for ACCESS TOXO IGG ASSAY ON THE ACCESS IMM... by Bio-Rad Laboratories, Inc.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K951495 · Bio-Rad Laboratories, Inc. · Microbiology device
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Dec 1995
Decision
264d
Days
Class 2
Risk

K951495 is an FDA 510(k) clearance for the ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on December 20, 1995 after a review of 264 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K951495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1995
Decision Date December 20, 1995
Days to Decision 264 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 102d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 70
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K951495.
AXSYM TOXO IGG ANTIBODY ASSAY
K954575 · Abbott Laboratories · Aug 1996
TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM
K955760 · Bayer Corp. · Aug 1996
IMMULITE TOXOPLASMA GONDII IGG
K950671 · Diagnostic Products Corp. · Feb 1996
IMX TOXO IGG
K951636 · Abbott Laboratories · Aug 1995
IMX(R) TOXO IGM
K945634 · Abbott Laboratories · Apr 1995
VIDAS TOXO COMPETITION (TXC) ASSAY
K931334 · Biomerieux Vitek, Inc. · Jun 1993