Cleared Traditional

K954158 - STC DIAGNOSTICS AUTO-LYTE PH ASSAY

K954158 is an FDA 510(k) clearance for STC DIAGNOSTICS AUTO-LYTE PH ASSAY, manufactured by Solarcare Technologies Corp,Inc.. The device is a Class 1 Chemistry device with product code KQO cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K954158 · Solarcare Technologies Corp,Inc. · Chemistry device
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Apr 1996
Decision
238d
Days
Class 1
Risk

K954158 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE PH 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 April 30, 1996 after a review of 238 days - an extended review cycle.

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. 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 Solarcare Technologies Corp,Inc. devices

FDA 510(k) Submission Details - K954158

510(k) Number K954158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date April 30, 1996
Days to Decision 238 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
150d slower than avg
Panel avg: 88d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

KQO Device Classification - Class 1, General Controls

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 33
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K954158.
UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE
K954514 · Sciteck Diagnostics, Inc. · Jun 1996
CLINITEK 50 URINE CHEMISTRY ANALYZER
K960546 · Bayer Corp. · Jun 1996
AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
K951877 · Chimera Research & Chemical, Inc. · May 1996
900UDX URINE PATHOLOGY SYSTEM
K960054 · Intl. Remote Imaging Systems · Mar 1996
CHEMSTRIP CRITERION URINE ANALYZER
K954024 · Boehringer Mannheim Corp. · Oct 1995
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
K946183 · Heraeus Kulzer, Inc. · Feb 1995