Cleared Traditional

K952802 - VISUWELL REAGIN II

K952802 is an FDA 510(k) clearance for VISUWELL REAGIN II, manufactured by Biomira Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K952802 · Biomira Diagnostics, Inc. · Microbiology device
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May 1996
Decision
339d
Days
Class 2
Risk

K952802 is an FDA 510(k) clearance for the VISUWELL REAGIN II. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Biomira Diagnostics, Inc. (Rexdale, Ontario, CA). The FDA issued a Cleared decision on May 23, 1996 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3820 - 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. Elevated predicate reliance profile. 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 Biomira Diagnostics, Inc. devices

FDA 510(k) Submission Details - K952802

510(k) Number K952802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1995
Decision Date May 23, 1996
Days to Decision 339 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
237d slower than avg
Panel avg: 102d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMQ Device Classification - Class 2, Special Controls

Product Code GMQ Antigens, Nontreponemal, All
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
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 - GMQ Antigens, Nontreponemal, All

All 21
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