Cleared Traditional

K954266 - STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY

K954266 is the FDA 510(k) clearance for STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY by Solarcare Technologies Corp,Inc.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K954266 · Solarcare Technologies Corp,Inc. · Chemistry device
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Oct 1995
Decision
31d
Days
Class 2
Risk

K954266 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on October 13, 1995 after a review of 31 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 Solarcare Technologies Corp,Inc. devices

Submission Details

510(k) Number K954266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1995
Decision Date October 13, 1995
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K954266.
RANDOX CREATININE
K973993 · Randox Laboratories, Ltd. · Mar 1998
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
K972743 · Sigma Diagnostics, Inc. · Sep 1997
SIGMA DIAGNOSTICS CREATININE REAGENT KIT
K963534 · Sigma Diagnostics, Inc. · Sep 1996
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
K951595 · Roche Diagnostic Systems, Inc. · Sep 1995
CREATININE-PO REAGENT KIT
K943924 · Synermed, Inc. · Sep 1994
ROCHE REAGENT FOR CREATININE
K941837 · Roche Diagnostic Systems, Inc. · Aug 1994