Cleared Traditional

K801054 - THROMBO-TEST (X)

K801054 is an FDA 510(k) clearance for THROMBO-TEST (X), manufactured by Medtro GmbH. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K801054 · Medtro GmbH · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
312d
Days
Class 2
Risk

K801054 is an FDA 510(k) clearance for the THROMBO-TEST (X). Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Medtro GmbH (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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.

FDA 510(k) Submission Details - K801054

510(k) Number K801054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1980
Decision Date March 13, 1981
Days to Decision 312 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 113d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 185
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K801054.
HEMATOLOGY CONTROL
K812280 · American Dade · Sep 1981
VENTREX DATA REDUCTION & QUAL. CONTR. SY
K812357 · Ventrex Laboratories, Inc. · Sep 1981
HEMOTOLOGY QUALITY CONTROL MIXTURES
K810756 · Scientific Standards, Inc. · Jun 1981
CBC PLT-4
K802265 · R&D Systems, Inc. · Nov 1980
PLT-4 SIZE-CHECK
K802267 · R&D Systems, Inc. · Nov 1980
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
K802141 · American Dade · Oct 1980
K801054 · THROMBO-TEST (X)
Download PDF Medtro GmbH