Cleared Traditional

K080811 - TINA-QUANT CYSTATIN C

K080811 is the FDA 510(k) clearance for TINA-QUANT CYSTATIN C by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code NDY) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K080811 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
88d
Days
Class 2
Risk

K080811 is an FDA 510(k) clearance for the TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATI.... Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 20, 2008 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K080811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2008
Decision Date June 20, 2008
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
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 8
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K080811.
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · Siemens Healthcare Diagnostics, Inc. · May 2018
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
K141143 · Roche Diagnostics · Jul 2014
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487
K083906 · Siemens Healthcare Diagnostics · Mar 2009
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
K080384 · The Binding Site, Ltd. · Jun 2008
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