Cleared Traditional

K911981 - HEMOCARD HEMOGLOBIN S

K911981 is the FDA 510(k) clearance for HEMOCARD HEMOGLOBIN S by Isolab, Inc.. It is a Class 2 Hematology device (product code GHM) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K911981 · Isolab, Inc. · Hematology device
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Oct 1991
Decision
159d
Days
Class 2
Risk

K911981 is an FDA 510(k) clearance for the HEMOCARD HEMOGLOBIN S. Classified as Test, Sickle Cell (product code GHM), Class II - Special Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 159 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7825 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Isolab, Inc. devices

Submission Details

510(k) Number K911981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1991
Decision Date October 09, 1991
Days to Decision 159 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 113d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHM Test, Sickle Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7825
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 - GHM Test, Sickle Cell

All 8
Devices cleared under the same product code (GHM) and FDA review panel - the closest regulatory comparables to K911981.
SICKLE-CHEX SOLUBILITY KIT
K023656 · Streck Laboratories, Inc. · Dec 2002
SICKLE-CHEX
K013316 · Streck Laboratories, Inc. · Nov 2001
SAS SICKLE CELL TEST
K960947 · Sa Scientific, Inc. · Jul 1996
HEMOCARD-AS
K910430 · Isolab, Inc. · Apr 1991
SICKLE CELL REAGENT SET
K860420 · Sterling Diagnostics, Inc. · Feb 1986
SICKLING HEMOGLOBIN CONTROLS, NORMAL
K842152 · Isolab, Inc. · Sep 1984