Cleared Traditional

K954332 - RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

K954332 is an FDA 510(k) clearance for RBCFOLATE ASSAY FOR THE TECHNICON IMMUN..., manufactured by Bayer Corp.. The device is a Class 2 Chemistry device with product code CGN cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K954332 · Bayer Corp. · Chemistry device
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Jan 1996
Decision
128d
Days
Class 2
Risk

K954332 is an FDA 510(k) clearance for the RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 128 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.

View all Bayer Corp. devices

FDA 510(k) Submission Details - K954332

510(k) Number K954332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date January 24, 1996
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 88d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGN Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K954332.
AIA-PACK FOLATE ASSAY
K964349 · Tosoh Medics, Inc. · Nov 1996
CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)
K960800 · Boehringer Mannheim Corp. · Jul 1996
ACCESS FOLATE ASSAY (MODIFICATION)
K955434 · Beckman Coulter, Inc. · Jan 1996
CEDIA FOLATE (NO BOIL) ASSAY
K951155 · Microgenics Corp. · Jun 1995
RADIAS RED CELL FOLATE IMMUNOASAY
K944212 · Bio-Rad · Feb 1995
CEDIA(R) FOLATE (NO BOIL) ASSAY
K946184 · Microgenics Corp. · Jan 1995