Cleared Traditional

K951155 - CEDIA FOLATE (NO BOIL) ASSAY

K951155 is the FDA 510(k) clearance for CEDIA FOLATE (NO BOIL) ASSAY by Microgenics Corp.. It is a Class 2 Chemistry device (product code CGN) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K951155 · Microgenics Corp. · Chemistry device
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Jun 1995
Decision
107d
Days
Class 2
Risk

K951155 is an FDA 510(k) clearance for the CEDIA FOLATE (NO BOIL) ASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on June 29, 1995 after a review of 107 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 Microgenics Corp. devices

Submission Details

510(k) Number K951155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1995
Decision Date June 29, 1995
Days to Decision 107 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
19d slower than avg
Panel avg: 88d · This submission: 107d
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 K951155.
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
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K954332 · Bayer Corp. · Jan 1996
RADIAS RED CELL FOLATE IMMUNOASAY
K944212 · Bio-Rad · Feb 1995
CEDIA(R) FOLATE (NO BOIL) ASSAY
K946184 · Microgenics Corp. · Jan 1995
CIBA CORNING ACS FOLATE ASSAY
K943297 · Ciba Corning Diagnostics Corp. · Dec 1994