Cleared Traditional

K955905 - STC DIAGNOSTICS AUTO-LYTE URINARY PROTE...

K955905 is an FDA 510(k) clearance for STC DIAGNOSTICS AUTO-LYTE URINARY PROTE..., manufactured by Solarcare Technologies Corp,Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K955905 · Solarcare Technologies Corp,Inc. · Chemistry device
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May 1996
Decision
153d
Days
Class 2
Risk

K955905 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 30, 1996 after a review of 153 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - 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 - K955905

510(k) Number K955905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1995
Decision Date May 30, 1996
Days to Decision 153 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
65d slower than avg
Panel avg: 88d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEK Device Classification - Class 2, Special Controls

Product Code CEK Biuret (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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 - CEK Biuret (colorimetric), Total Protein

All 82
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K955905.
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
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DUPONT DIMENSION TOTAL PROTEIN METHOD
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TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
K950234 · Emd Chemicals, Inc. · Jun 1995
TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
K950128 · Emd Chemicals, Inc. · May 1995
TOTAL PROTEIN QVET
K943004 · Prisma Systems · Dec 1994