Cleared Traditional

K962936 - IMMULITE TOXOPLASMA QUANTITATIVE IGG

K962936 is an FDA 510(k) clearance for IMMULITE TOXOPLASMA QUANTITATIVE IGG, manufactured by Diagnostic Products Corp.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K962936 · Diagnostic Products Corp. · Microbiology device
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Apr 1997
Decision
269d
Days
Class 2
Risk

K962936 is an FDA 510(k) clearance for the IMMULITE TOXOPLASMA QUANTITATIVE IGG. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 24, 1997 after a review of 269 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K962936

510(k) Number K962936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1996
Decision Date April 24, 1997
Days to Decision 269 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
167d slower than avg
Panel avg: 102d · This submission: 269d
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 94
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K962936.
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INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
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INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
K963296 · Incstar Corp. · Dec 1996
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
K963297 · Incstar Corp. · Dec 1996