Cleared Traditional

K920531 - WAKO AUTOKIT MICRO TP

K920531 is an FDA 510(k) clearance for WAKO AUTOKIT MICRO TP, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K920531 · Wako Chemicals USA, Inc. · Chemistry device
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Jul 1992
Decision
160d
Days
Class 2
Risk

K920531 is an FDA 510(k) clearance for the WAKO AUTOKIT MICRO TP. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on July 14, 1992 after a review of 160 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K920531

510(k) Number K920531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1992
Decision Date July 14, 1992
Days to Decision 160 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
72d slower than avg
Panel avg: 88d · This submission: 160d
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 100
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K920531.
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
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K922361 · Olympus Corp. · Jul 1992
MICROPROTEIN-PR
K915380 · Sigma Diagnostics, Inc. · Feb 1992
BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST
K914885 · Beckman Instruments, Inc. · Jan 1992
URINE/CSF MICROPROTEIN REAGENT
K913225 · Intersect Systems, Inc. · Oct 1991