Cleared Traditional

K875310 - RETICULOCYTE STAIN

K875310 is an FDA 510(k) clearance for RETICULOCYTE STAIN, manufactured by Sigma Diagnostics, Inc.. The device is a Class 1 Pathology device with product code KFC cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K875310 · Sigma Diagnostics, Inc. · Pathology device
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Feb 1988
Decision
42d
Days
Class 1
Risk

K875310 is an FDA 510(k) clearance for the RETICULOCYTE STAIN. Classified as Methylene Blue, Tissue Stain (product code KFC), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 9, 1988 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - the FDA pathology 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

FDA 510(k) Submission Details - K875310

510(k) Number K875310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1987
Decision Date February 09, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 77d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

KFC Device Classification - Class 1, General Controls

Product Code KFC Methylene Blue, Tissue Stain
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KFC Methylene Blue, Tissue Stain

Devices cleared under the same product code (KFC) and FDA review panel - the closest regulatory comparables to K875310.
SPOTTEST LOEFFLER METHYLENE BLUE STAIN
K843919 · Difco Laboratories, Inc. · Oct 1984
STAIN, METHYLENE BLUE-EOSIN
K842785 · Reagent Laboratory, Inc. · Sep 1984
METHYLENE BLUE STAIN, LOEFFLER
K842926 · E K Ind., Inc. · Sep 1984
NEW METHYLENE BLUE N
K842743 · E K Ind., Inc. · Aug 1984
TUBE, STAIN, RETICULOCYTE, LARC
K770792 · Corning Medical & Scientific · Jul 1977