Cleared Traditional

K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL (K093137) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093137 · Kamiya Biomedical Co. · Chemistry device
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Sep 2010
Decision
358d
Days
Class 2
Risk

K093137 is an FDA 510(k) clearance for the K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL. Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Tukwila, US). The FDA issued a Cleared decision on September 28, 2010 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 Kamiya Biomedical Co. devices

Submission Details

510(k) Number K093137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2009
Decision Date September 28, 2010
Days to Decision 358 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
270d slower than avg
Panel avg: 88d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDY Test, Cystatin C
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - NDY Test, Cystatin C

All 21
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ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · Siemens Healthcare Diagnostics, Inc. · May 2018
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH
K063351 · Dade Behring, Inc. · Jan 2007
N LATEX CYSTATIN
K041878 · Dade Behring, Inc. · Aug 2004
N LATEX CYSTATIN C
K003503 · Dade Behring, Inc. · Mar 2001