Cleared Traditional

K935286 - QUANTAPHASE II B12/FOLATE

K935286 is the FDA 510(k) clearance for QUANTAPHASE II B12/FOLATE by Bio-Rad. It is a Class 2 Chemistry device (product code CGN) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K935286 · Bio-Rad · Chemistry device
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Feb 1994
Decision
137d
Days
Class 2
Risk

K935286 is an FDA 510(k) clearance for the QUANTAPHASE II B12/FOLATE. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on February 18, 1994 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K935286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1993
Decision Date February 18, 1994
Days to Decision 137 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGN Acid, Folic, Radioimmunoassay

All 50
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K935286.
CIBA CORNING ACS FOLATE ASSAY
K943297 · Ciba Corning Diagnostics Corp. · Dec 1994
FOLIC ACID
K943705 · Diagnostic Products Corp. · Oct 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
K943149 · Beckman Coulter, Inc. · Aug 1994
VISTA FOLATE ASSAY
K934121 · Syva Co. · Oct 1993
ACCESS FOLATE ASSAY
K932887 · Beckman Coulter, Inc. · Oct 1993
RADIAS FOLATE ENZYME IMMUNOASSAY
K933571 · Bio-Rad · Oct 1993