Cleared Traditional

K881400 - CREATININE FOR CONTINUOUS FLOW INSTRUMENTS

K881400 is an FDA 510(k) clearance for CREATININE FOR CONTINUOUS FLOW INSTRUMENTS, manufactured by Catachem, Inc.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K881400 · Catachem, Inc. · Chemistry device
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Apr 1988
Decision
24d
Days
Class 2
Risk

K881400 is an FDA 510(k) clearance for the CREATININE FOR CONTINUOUS FLOW INSTRUMENTS. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on April 28, 1988 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Catachem, Inc. devices

FDA 510(k) Submission Details - K881400

510(k) Number K881400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date April 28, 1988
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 142
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K881400.
HI CHEM CREATININE REAGENT (PRODUCT #88809)
K890671 · Hichem Diagnostics · May 1989
CREATININE TEST (CREA) ITEM #65663
K884734 · Em Diagnostic Systems, Inc. · Dec 1988
BIOTROL CREATININE H.P. REAGENT
K881856 · Biotrol, USA, Inc. · Jun 1988
CREATININE REAGENT SET (KINETIC)
K880843 · Tech-Neal Scientific, Inc. · Apr 1988
CREATININE
K880629 · Tech-Co, Inc. · Mar 1988
PARAMAX CREATININE REAGENT
K873531 · Baxter Healthcare Corp · Nov 1987