Cleared Traditional

K973274 - ACCUCOLOR HIGH CALIBRATOR (A3089)

K973274 is the FDA 510(k) clearance for ACCUCOLOR HIGH CALIBRATOR (A3089) by Sigma Diagnostics, Inc.. It is a Class 2 Hematology device (product code GIZ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K973274 · Sigma Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
59d
Days
Class 2
Risk

K973274 is an FDA 510(k) clearance for the ACCUCOLOR HIGH CALIBRATOR (A3089). Classified as Plasma, Control, Normal (product code GIZ), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 31, 1997 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device 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 K973274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1997
Decision Date October 31, 1997
Days to Decision 59 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 113d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GIZ Plasma, Control, Normal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 Hematology devices follow this clearance model.

Regulatory Peers - GIZ Plasma, Control, Normal

All 12
Devices cleared under the same product code (GIZ) and FDA review panel - the closest regulatory comparables to K973274.
CONTROL PLASMA N
K023309 · Dade Behring, Inc. · Nov 2002
ACCUCLOT CONTROL I, MODEL A4089
K003328 · Sigma Diagnostics, Inc. · Mar 2001
CONTROL PLASMA N
K001256 · Dade Behring, Inc. · May 2000
SPECIALTY ASSAYED CONTROL-1
K941737 · Helena Laboratories · Oct 1994
CONTROL PLASMA N
K924403 · Behring Diagnostics, Inc. · Feb 1994
COAGULATION REFERENCE PLASMA, NORMAL
K932145 · American Diagnostic Corp. · Oct 1993