Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY (K954156) - FDA 510(k) Clearance

Class I Chemistry device.

K954156 · Solarcare Technologies Corp,Inc. · Chemistry device
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Jul 1996
Decision
321d
Days
Class 1
Risk

K954156 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - 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. Elevated predicate reliance profile. 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 Solarcare Technologies Corp,Inc. devices

Submission Details

510(k) Number K954156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date July 22, 1996
Days to Decision 321 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 88d · This submission: 321d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KQO Automated Urinalysis System

All 45
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K954156.
CHEMSTRIP 101 URINE ANALYZER
K983510 · Boehringer Mannheim Corp. · Oct 1998
CHEMSTRIP CRITERION URINE ANALYZER
K954024 · Boehringer Mannheim Corp. · Oct 1995
CHEMSTRIP MINI UA URINE ANALYZER
K943592 · Boehringer Mannheim Corp. · Nov 1994
CHEMSTRIP SUPER UA URINE ANALYZER
K934042 · Boehringer Mannheim Corp. · Oct 1993
CHEMSTRIP URINE ANALYZER
K931602 · Boehringer Mannheim Corp. · Jun 1993
CHEMSTRIP URINE ANALYZER
K921087 · Boehringer Mannheim Corp. · Mar 1992