Cleared Traditional

K874594 - TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560

K874594 is an FDA 510(k) clearance for TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560, manufactured by Clinical Sciences, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K874594 · Clinical Sciences, Inc. · Microbiology device
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Mar 1988
Decision
119d
Days
Class 2
Risk

K874594 is an FDA 510(k) clearance for the TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Clinical Sciences, Inc. (Whippany, US). The FDA issued a Cleared decision on March 7, 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 Clinical Sciences, Inc. devices

FDA 510(k) Submission Details - K874594

510(k) Number K874594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date March 07, 1988
Days to Decision 119 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

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 95
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K874594.
BIOTROL TOXO ELISA TEST M
K873293 · Biotrol, USA, Inc. · Apr 1988
BIOTROL TOXO ELISA TEST G
K873294 · Biotrol, USA, Inc. · Apr 1988
TOXOSTAT M TEST KIT
K875113 · Whittaker Bioproducts, Inc. · Apr 1988
DETECTADOT SYSTEM 2000 TOXO IGG TEST
K875109 · Gull Laboratories, Inc. · Mar 1988
CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY
K871746 · Mercia Diagnostics , Ltd. · Jul 1987
TOXOPLASMA GONDII IGG ELISA
K871905 · Electro-Nucleonics Laboratories, Inc. · Jul 1987