Cleared Traditional

HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER (K080384) - FDA 510(k) Clearance

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

K080384 · The Binding Site, Ltd. · Chemistry device
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Jun 2008
Decision
114d
Days
Class 2
Risk

K080384 is an FDA 510(k) clearance for the HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER. Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on June 6, 2008 after a review of 114 days - within the typical 510(k) review window.

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. 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 The Binding Site, Ltd. devices

Submission Details

510(k) Number K080384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2008
Decision Date June 06, 2008
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 88d · This submission: 114d
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
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K080384.
Cystatin C
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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