Cleared Traditional

K960947 - SAS SICKLE CELL TEST

K960947 is an FDA 510(k) clearance for SAS SICKLE CELL TEST, manufactured by Sa Scientific, Inc.. The device is a Class 2 Hematology device with product code GHM cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K960947 · Sa Scientific, Inc. · Hematology device
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Jul 1996
Decision
115d
Days
Class 2
Risk

K960947 is an FDA 510(k) clearance for the SAS SICKLE CELL TEST. Classified as Test, Sickle Cell (product code GHM), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 1, 1996 after a review of 115 days - within the typical 510(k) review window.

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 Sa Scientific, Inc. devices

FDA 510(k) Submission Details - K960947

510(k) Number K960947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1996
Decision Date July 01, 1996
Days to Decision 115 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
2d slower than avg
Panel avg: 113d · This submission: 115d
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 K960947.
SICKLE-CHEX SOLUBILITY KIT
K023656 · Streck Laboratories, Inc. · Dec 2002
SICKLE-CHEX
K013316 · Streck Laboratories, Inc. · Nov 2001
HEMOCARD HEMOGLOBIN S
K911981 · Isolab, Inc. · Oct 1991
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