Cleared Traditional

K875113 - TOXOSTAT M TEST KIT

K875113 is the FDA 510(k) clearance for TOXOSTAT M TEST KIT by Whittaker Bioproducts, Inc.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K875113 · Whittaker Bioproducts, Inc. · Microbiology device
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Apr 1988
Decision
119d
Days
Class 2
Risk

K875113 is an FDA 510(k) clearance for the TOXOSTAT M TEST KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on April 12, 1988 after a review of 119 days - within the typical 510(k) review window.

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 Whittaker Bioproducts, Inc. devices

Submission Details

510(k) Number K875113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1987
Decision Date April 12, 1988
Days to Decision 119 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 102d · This submission: 119d
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 78
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K875113.
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
K883936 · Ortho Diagnostic Systems, Inc. · Oct 1988
BIOTROL TOXO ELISA TEST M
K873293 · Biotrol, USA, Inc. · Apr 1988
BIOTROL TOXO ELISA TEST G
K873294 · Biotrol, USA, Inc. · Apr 1988
DETECTADOT SYSTEM 2000 TOXO IGG TEST
K875109 · Gull Laboratories, Inc. · Mar 1988
TOXOPLASMA GONDII IGG ELISA
K871905 · Electro-Nucleonics Laboratories, Inc. · Jul 1987
TOXOPLASMA IGM MICROASSAY
K870753 · Diamedix Corp. · Apr 1987