Cleared Traditional

K911981 - HEMOCARD HEMOGLOBIN S

K911981 is an FDA 510(k) clearance for HEMOCARD HEMOGLOBIN S, manufactured by Isolab, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K911981

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.

GHM Device Classification - Class 2, Special Controls

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 12
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
THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT
K872217 · Pacific Hemostasis · Jul 1987
SICKLE CELL REAGENT SET
K860420 · Sterling Diagnostics, Inc. · Feb 1986