Cleared Abbreviated

K082141 - ARCHITECT C-PEPTIDE CALIBRATORS

K082141 is the FDA 510(k) clearance for ARCHITECT C-PEPTIDE CALIBRATORS by Biokit, S.A.. It is a Class 2 Chemistry device (product code JIT) cleared through the Abbreviated 510(k) pathway after a 35-day FDA review.

K082141 · Biokit, S.A. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
35d
Days
Class 2
Risk

K082141 is an FDA 510(k) clearance for the ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L5.... Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on September 3, 2008 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Biokit, S.A. devices

Submission Details

510(k) Number K082141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2008
Decision Date September 03, 2008
Days to Decision 35 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 160
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K082141.
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
K083462 · Siemens Healthcare Diagnostics · Feb 2009
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
K082680 · Siemens Healthcare Diagnostics · Oct 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
K081789 · Siemens Healthcare Diagnostics, Inc. · Sep 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
K081319 · Siemens Healthcare Diagnostics, Inc. · Aug 2008
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
K081683 · Siemens Healthcare Diagnostics · Jul 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
K080166 · Beckman Coulter, Inc. · Mar 2008