Cleared Traditional

K062503 - CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT

K062503 is an FDA 510(k) clearance for CATACHEM, manufactured by Catachem, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K062503

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.

KWW Device Classification - Class 2, Special Controls

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