Cleared Traditional

K942632 - TNT TROPONIN T

K942632 is an FDA 510(k) clearance for TNT TROPONIN T, manufactured by Streck Laboratories, Inc.. The device is a Class 1 Immunology device with product code JJX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K942632 · Streck Laboratories, Inc. · Immunology device
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Sep 1994
Decision
98d
Days
Class 1
Risk

K942632 is an FDA 510(k) clearance for the TNT TROPONIN T. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Streck Laboratories, Inc. devices

FDA 510(k) Submission Details - K942632

510(k) Number K942632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1994
Decision Date September 09, 1994
Days to Decision 98 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 105d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 445
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