Cleared Traditional

K010652 - SIGMA DIAGNOSTICS SIGMA-CAL

K010652 is the FDA 510(k) clearance for SIGMA DIAGNOSTICS SIGMA-CAL by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K010652 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
25d
Days
Class 2
Risk

K010652 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 30, 2001 after a review of 25 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 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K010652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date March 30, 2001
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
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 - JIX Calibrator, Multi-analyte Mixture

All 201
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K010652.
RAICHEM MULTI-ANALYTE CALIBRATOR
K012250 · Hemagen Diagnostics, Inc. · Sep 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226 · Roche Diagnostics Corp. · Jun 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
K011035 · Dade Behring, Inc. · Jun 2001
N PROTEIN STANDARD SL
K002804 · Dade Behring, Inc. · Oct 2000
ELECSYS CORTISOL CALCHECK
K000576 · Roche Diagnostics Corp. · Mar 2000
K-ASSAY MULTI-ANALYTE CALIBRATOR
K993853 · Kamiya Biomedical Co. · Dec 1999