Cleared Traditional

K991109 - CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02

K991109 is an FDA 510(k) clearance for CREATININE REAGENT, manufactured by A.P. Total Care, Inc.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K991109 · A.P. Total Care, Inc. · Chemistry device
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May 1999
Decision
54d
Days
Class 2
Risk

K991109 is an FDA 510(k) clearance for the CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on May 25, 1999 after a review of 54 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 A.P. Total Care, Inc. devices

FDA 510(k) Submission Details - K991109

510(k) Number K991109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date May 25, 1999
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
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 140
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K991109.
CREATININE
K003247 · Jas Diagnostics, Inc. · Dec 2000
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
K001769 · Ortho-Clinical Diagnostics · Jun 2000
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055 · Diagnostic Chemicals , Ltd. · Feb 2000
DUAL VIAL CREATININE REAGENT
K983937 · Intersect Systems, Inc. · Jan 1999
CREA
K981799 · Abbott Laboratories · Jul 1998
CREATININE (CREA)
K981240 · Abbott Laboratories · May 1998