Cleared Traditional

K952385 - HEMA-TROL Q-CHECK

K952385 is an FDA 510(k) clearance for HEMA-TROL Q-CHECK, manufactured by Medical Specialties Intl., Inc.. The device is a Class 1 Hematology device with product code JJY cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K952385 · Medical Specialties Intl., Inc. · Hematology device
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Sep 1995
Decision
126d
Days
Class 1
Risk

K952385 is an FDA 510(k) clearance for the HEMA-TROL Q-CHECK. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Medical Specialties Intl., Inc. (South Plainfield, US). The FDA issued a Cleared decision on September 25, 1995 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1660 - 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 Specialties Intl., Inc. devices

FDA 510(k) Submission Details - K952385

510(k) Number K952385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1995
Decision Date September 25, 1995
Days to Decision 126 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 113d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 580
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