Cleared Traditional

K955115 - VENOM TIEM REAGENT

K955115 is the FDA 510(k) clearance for VENOM TIEM REAGENT by Medical Diagnostic Technologies, Inc.. It is a Class 2 Hematology device (product code JCO) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K955115 · Medical Diagnostic Technologies, Inc. · Hematology device
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Apr 1996
Decision
146d
Days
Class 2
Risk

K955115 is an FDA 510(k) clearance for the VENOM TIEM REAGENT. Classified as Bothrops Atrox Reagent (product code JCO), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on April 3, 1996 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8100 - 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 Medical Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K955115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1995
Decision Date April 03, 1996
Days to Decision 146 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
33d slower than avg
Panel avg: 113d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCO Bothrops Atrox Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8100
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 - JCO Bothrops Atrox Reagent

Devices cleared under the same product code (JCO) and FDA review panel - the closest regulatory comparables to K955115.
BATROXOBIN REAGENT
K932787 · Behring Diagnostics, Inc. · Nov 1993
FDP COLLECTION TUBES
K896033 · Medical Diagnostic Technologies, Inc. · Oct 1989
DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE
K852519 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1985
REPTILASE -PC
K843207 · Bio/Data Corp. · Oct 1984
ATROXIN
K780355 · Sigma Chemical Co. · Apr 1978