Cleared Traditional

K963533 - SIGMA DIAGNOSTIC CX -3 CALIBRATION STAN...

K963533 is the FDA 510(k) clearance for SIGMA DIAGNOSTIC CX -3 CALIBRATION STAN... by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K963533 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
55d
Days
Class 2
Risk

K963533 is an FDA 510(k) clearance for the SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1. 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 October 29, 1996 after a review of 55 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 K963533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1996
Decision Date October 29, 1996
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 K963533.
N PROTEIN STRANDARD SL
K964062 · Behring Diagnostics, Inc. · Nov 1996
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
K963543 · Sigma Diagnostics, Inc. · Oct 1996
CEDIA CARDIAC TDM MULTI-CALS
K962269 · Boehringer Mannheim Corp. · Oct 1996
DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR
K962629 · Casco Standards · Sep 1996
N CRP STANDARD SY
K962406 · Behring Diagnostics, Inc. · Jul 1996
N PROTEIN STANDARD PY
K962410 · Behring Diagnostics, Inc. · Jul 1996