Cleared Traditional

K896373 - 1400 SERIES EVIDENCE COLLECTION KIT (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896373 · Transidyne General Corp. · Pathology device
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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

Submission Details

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
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.

Device Classification

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 38
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K896373.
BD Vacutainer® Citrate Blood Collection Tubes
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BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
K213670 · Becton, Dickinson and Company · Aug 2023