Cleared Traditional

K963289 - INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY

K963289 is an FDA 510(k) clearance for INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY, manufactured by Incstar Corp.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K963289 · Incstar Corp. · Microbiology device
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May 1997
Decision
253d
Days
Class 2
Risk

K963289 is an FDA 510(k) clearance for the INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on May 1, 1997 after a review of 253 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 Incstar Corp. devices

FDA 510(k) Submission Details - K963289

510(k) Number K963289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1996
Decision Date May 01, 1997
Days to Decision 253 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
151d slower than avg
Panel avg: 102d · This submission: 253d
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 K963289.
QUANTA LITE TOXOPLASMA IGG
K971441 · Inova Diagnostics, Inc. · Dec 1997
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K971989 · Bayer Corp. · Oct 1997
SERAQUEST TOXOPLASMA IGM
K971672 · Quest Intl., Inc. · Oct 1997
IMMULITE TOXOPLASMA QUANTITATIVE IGG
K962936 · Diagnostic Products Corp. · Apr 1997
TOXO IGG ELISA TEST
K962343 · Gull Laboratories, Inc. · Mar 1997
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
K963296 · Incstar Corp. · Dec 1996