Cleared Traditional

K961892 - SPECKTIN-LA TEST SET

K961892 is an FDA 510(k) clearance for SPECKTIN-LA TEST SET, manufactured by Analytical Control Systems, Inc.. The device is a Class 2 Hematology device with product code GFO cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K961892 · Analytical Control Systems, Inc. · Hematology device
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Mar 1997
Decision
295d
Days
Class 2
Risk

K961892 is an FDA 510(k) clearance for the SPECKTIN-LA TEST SET. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Analytical Control Systems, Inc. (Fishers, US). The FDA issued a Cleared decision on March 7, 1997 after a review of 295 days - an extended review cycle.

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 Analytical Control Systems, Inc. devices

FDA 510(k) Submission Details - K961892

510(k) Number K961892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date March 07, 1997
Days to Decision 295 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
182d slower than avg
Panel avg: 113d · This submission: 295d
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 K961892.
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712 · Sigma Diagnostics, Inc. · Dec 1999
HEMOCHRON CITRATE APTT
K972831 · International Technidyne Corp. · Nov 1997
IL TEST APTT-SP
K973306 · Instrumentation Laboratory CO · Nov 1997
SYNTHAFAX APTT REAGENT
K955638 · Ortho Diagnostic Systems, Inc. · Apr 1996
PATHROMTIN SL
K955450 · Behring Diagnostics, Inc. · Apr 1996
SYNTHASIL APTT REAGENT
K953981 · Ortho Diagnostic Systems, Inc. · Nov 1995