Cleared Traditional

K062503 - CATACHEM

K062503 is the FDA 510(k) clearance for CATACHEM by Catachem, Inc.. It is a Class 2 Chemistry device (product code KWW) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K062503 · Catachem, Inc. · Chemistry device
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Jan 2007
Decision
147d
Days
Class 2
Risk

K062503 is an FDA 510(k) clearance for the CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT. Classified as Radioimmunoassay, Cholyglycine, Bile Acids (product code KWW), Class II - Special Controls.

Submitted by Catachem, Inc. (Bridgeport, US). The FDA issued a Cleared decision on January 19, 2007 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1177 - 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 Catachem, Inc. devices

Submission Details

510(k) Number K062503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2006
Decision Date January 19, 2007
Days to Decision 147 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
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWW Radioimmunoassay, Cholyglycine, Bile Acids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1177
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 - KWW Radioimmunoassay, Cholyglycine, Bile Acids

Devices cleared under the same product code (KWW) and FDA review panel - the closest regulatory comparables to K062503.
TOTAL BILE ACIDS ASSAY, MODEL DZ042A
K051714 · Diazyme Laboratories · Dec 2005
BILE ACIDS REAGENT SET
K970120 · Teco Diagnostics · Mar 1997
BILE ACIDS REAGENT
K872296 · Sigma Diagnostics, Inc. · Aug 1987
ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT
K803296 · Immunotech Corp. · Jan 1981
CONJUGATED BILE ACIDS RIA KIT
K781337 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978