Cleared Traditional

FLOW CYTOMETRY FITC/PE COMPENSATION KIT (K910255) - FDA 510(k) Clearance

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

K910255 · Sigma Diagnostics, Inc. · Hematology device
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Apr 1991
Decision
71d
Days
Class 2
Risk

K910255 is an FDA 510(k) clearance for the FLOW CYTOMETRY FITC/PE COMPENSATION KIT. Classified as Calibrator, Surrogate (product code JIW), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 3, 1991 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1150 - 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 K910255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date April 03, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 113d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIW Calibrator, Surrogate
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 Hematology devices follow this clearance model.

Regulatory Peers - JIW Calibrator, Surrogate

All 16
Devices cleared under the same product code (JIW) and FDA review panel - the closest regulatory comparables to K910255.
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
K902575 · Diagnostic Products Corp. · Oct 1990
ACCUSCAN MICROBEAD STANDARDS
K902294 · Sigma Chemical Co. · Jul 1990
UNIMETER CALIBRATION KIT
K880610 · Boehringer Mannheim Corp. · Mar 1988
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1980