Cleared Traditional

K935702 - DADE INNOVIN II

K935702 is the FDA 510(k) clearance for DADE INNOVIN II by Baxter Diagnostics, Inc.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K935702 · Baxter Diagnostics, Inc. · Hematology device
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Nov 1994
Decision
357d
Days
Class 2
Risk

K935702 is an FDA 510(k) clearance for the DADE INNOVIN II. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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. Elevated predicate reliance profile. 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 Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K935702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1993
Decision Date November 22, 1994
Days to Decision 357 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
244d slower than avg
Panel avg: 113d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 94
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K935702.
COAGUCHEK SYSTEM
K942884 · Boehringer Mannheim Corp. · May 1995
HEMOCHRON HNPT/FACTOR VI PT+
K945078 · International Technidyne Corp. · Apr 1995
ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
K935748 · Ortho Diagnostic Systems, Inc. · Apr 1995
MICROCOAGULATION PROTHROMBIN TIME TEST
K940432 · International Technidyne Corp. · May 1994
HELENA THROMBOPLASTIN-MI REAGENT
K940310 · Helena Laboratories · Apr 1994
ASSESS(TM) LOW ABNORMAL CONTROL
K931117 · Instrumentation Laboratory CO · Mar 1994