Cleared Traditional

K954326 - STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY

K954326 is an FDA 510(k) clearance for STC DIAGNOSTICS AUTO-LYTE URINARY HEMOG..., manufactured by Solarcare Technologies Corp,Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K954326 · Solarcare Technologies Corp,Inc. · Chemistry device
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Jul 1996
Decision
312d
Days
Class 2
Risk

K954326 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 23, 1996 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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

FDA 510(k) Submission Details - K954326

510(k) Number K954326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1995
Decision Date July 23, 1996
Days to Decision 312 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
224d slower than avg
Panel avg: 88d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 218
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