Cleared Traditional

K981263 - TOXOGEN

K981263 is an FDA 510(k) clearance for TOXOGEN, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Microbiology device with product code GMM cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K981263 · Instrumentation Laboratory CO · Microbiology device
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Aug 1998
Decision
121d
Days
Class 2
Risk

K981263 is an FDA 510(k) clearance for the TOXOGEN. Classified as Antigens, Iha, Toxoplasma Gondii (product code GMM), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 6, 1998 after a review of 121 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K981263

510(k) Number K981263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1998
Decision Date August 06, 1998
Days to Decision 121 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
19d slower than avg
Panel avg: 102d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMM Device Classification - Class 2, Special Controls

Product Code GMM Antigens, Iha, 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.