Cleared Traditional

K935702 - DADE INNOVIN II

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

K935702 · Baxter Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K935702

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.

GJS Device Classification - Class 2, Special Controls

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 113
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K935702.
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
THROMBOSCREEN THROMBOPLASTIN-DS
K940082 · Pacific Hemostasis · Feb 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