Cleared Traditional

K961864 - CSF/URINE TOTAL PROTEIN

K961864 is an FDA 510(k) clearance for CSF/URINE TOTAL PROTEIN, manufactured by Teco Diagnostics. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K961864 · Teco Diagnostics · Chemistry device
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Oct 1996
Decision
163d
Days
Class 2
Risk

K961864 is an FDA 510(k) clearance for the CSF/URINE TOTAL PROTEIN. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Teco Diagnostics (Placentia, US). The FDA issued a Cleared decision on October 24, 1996 after a review of 163 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 Teco Diagnostics devices

FDA 510(k) Submission Details - K961864

510(k) Number K961864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1996
Decision Date October 24, 1996
Days to Decision 163 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
75d slower than avg
Panel avg: 88d · This submission: 163d
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 96
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K961864.
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
K973108 · Diagnostic Chemicals , Ltd. · Mar 1998
TOTAL PROTEIN OR TP
K971524 · Carolina Liquid Chemistries Corp. · May 1997
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
K955905 · Solarcare Technologies Corp,Inc. · May 1996
DUPONT DIMENSION TOTAL PROTEIN METHOD
K950920 · Dupont Medical Products · Aug 1995
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