Cleared Traditional

K896373 - 1400 SERIES EVIDENCE COLLECTION KIT

K896373 is an FDA 510(k) clearance for 1400 SERIES EVIDENCE COLLECTION KIT, manufactured by Transidyne General Corp.. The device is a Class 2 Pathology device with product code GIM cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K896373 · Transidyne General Corp. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
112d
Days
Class 2
Risk

K896373 is an FDA 510(k) clearance for the 1400 SERIES EVIDENCE COLLECTION KIT. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Transidyne General Corp. (Ann Arbor, US). The FDA issued a Cleared decision on February 26, 1990 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.1675 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Transidyne General Corp. devices

FDA 510(k) Submission Details - K896373

510(k) Number K896373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date February 26, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 77d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIM Device Classification - Class 2, Special Controls

Product Code GIM Tubes, Vacuum Sample, With Anticoagulant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Pathology devices follow this clearance model.

Regulatory Peers - GIM Tubes, Vacuum Sample, With Anticoagulant

All 29
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K896373.
VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET
K921636 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
VACUTAINER KIT
K914901 · Abbott Laboratories · Jan 1992
CORVAC BLOOD COLLECTION TUBE
K915213 · Sherwood Medical Co. · Jan 1992
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
K896514 · Radiometer America, Inc. · Jan 1990
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
K882501 · Terumo Medical Corp. · Jul 1988
VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
K861449 · Exel Intl. · Sep 1986