Cleared Traditional

ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL (K974261) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974261 · Boston Biomedica, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Dec 1997
Decision
28d
Days
Class 2
Risk

K974261 is an FDA 510(k) clearance for the ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL. Classified as Antisera, If, Toxoplasma Gondii (product code LJK), Class II - Special Controls.

Submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on December 11, 1997 after a review of 28 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 Boston Biomedica, Inc. devices

Submission Details

510(k) Number K974261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1997
Decision Date December 11, 1997
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJK Antisera, 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.