Cleared Traditional

K943297 - CIBA CORNING ACS FOLATE ASSAY

K943297 is an FDA 510(k) clearance for CIBA CORNING ACS FOLATE ASSAY, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code CGN cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K943297 · Ciba Corning Diagnostics Corp. · Chemistry device
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Dec 1994
Decision
157d
Days
Class 2
Risk

K943297 is an FDA 510(k) clearance for the CIBA CORNING ACS FOLATE ASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on December 12, 1994 after a review of 157 days - an extended review cycle.

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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K943297

510(k) Number K943297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1994
Decision Date December 12, 1994
Days to Decision 157 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
69d slower than avg
Panel avg: 88d · This submission: 157d
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 54
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K943297.
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
FOLIC ACID
K943705 · Diagnostic Products Corp. · Oct 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
K943149 · Beckman Coulter, Inc. · Aug 1994
QUANTAPHASE II B12/FOLATE
K935286 · Bio-Rad · Feb 1994