Cleared Traditional

K781549 - TOXELISA TEST KIT

K781549 is the FDA 510(k) clearance for TOXELISA TEST KIT by Microbiological Assoc.. It is a Class 2 Microbiology device (product code GLZ) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K781549 · Microbiological Assoc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1978
Decision
86d
Days
Class 2
Risk

K781549 is an FDA 510(k) clearance for the TOXELISA TEST KIT. Classified as Antigens, If, Toxoplasma Gondii (product code GLZ), Class II - Special Controls.

Submitted by Microbiological Assoc. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1978 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microbiological Assoc. devices

Submission Details

510(k) Number K781549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1978
Decision Date December 07, 1978
Days to Decision 86 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 102d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GLZ Antigens, If, 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 - GLZ Antigens, If, Toxoplasma Gondii

All 9
Devices cleared under the same product code (GLZ) and FDA review panel - the closest regulatory comparables to K781549.
TOXOPLASMA ANTIBODY TEST SYSTEM
K791571 · Zeus Scientific, Inc. · Sep 1979
FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO
K790464 · Intl. Diagnostic Technology · Jun 1979
QUANTAZYME TOXOPLASMA
K790360 · Bio-Rad · May 1979
IMMUNOZYME TOXOPLASMA ANTIBODY
K780352 · Millipore Corp. · Jun 1978
TOXO TEST
K772243 · Gull Laboratories, Inc. · Dec 1977