Cleared Traditional

K992712 - SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334

K992712 is an FDA 510(k) clearance for SIGMA DIAGNOSTICS ALEXIN LS, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GFO cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K992712 · Sigma Diagnostics, Inc. · Hematology device
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Dec 1999
Decision
117d
Days
Class 2
Risk

K992712 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 6, 1999 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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 Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K992712

510(k) Number K992712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1999
Decision Date December 06, 1999
Days to Decision 117 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 113d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 43
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K992712.
HEMOSIL SYNTHASIL
K060688 · Instrumentation Laboratory CO · Apr 2006
HEMOSIL SILICA CLOTTING TIME
K050221 · Instrumentation Laboratory CO · Mar 2005
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711 · Sigma Diagnostics, Inc. · Dec 1999
HEMOCHRON CITRATE APTT
K972831 · International Technidyne Corp. · Nov 1997
IL TEST APTT-SP
K973306 · Instrumentation Laboratory CO · Nov 1997
SPECKTIN-LA TEST SET
K961892 · Analytical Control Systems, Inc. · Mar 1997