Cleared Traditional

K961892 - SPECKTIN-LA TEST SET

K961892 is the FDA 510(k) clearance for SPECKTIN-LA TEST SET by Analytical Control Systems, Inc.. It is a Class 2 Hematology device (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

Submission Details

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.

Device Classification

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 36
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