Cleared Traditional

K915325 - TSH CONTROL

K915325 is an FDA 510(k) clearance for TSH CONTROL, manufactured by Polymedco, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K915325 · Polymedco, Inc. · Chemistry device
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Mar 1992
Decision
101d
Days
Class 1
Risk

K915325 is an FDA 510(k) clearance for the TSH CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Polymedco, Inc. devices

FDA 510(k) Submission Details - K915325

510(k) Number K915325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date March 02, 1992
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
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 434
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K915325.
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HCG CONTROL
K921206 · Polymedco, Inc. · Apr 1992
MILENIA DATA REDUCTION
K915806 · Diagnostic Products Corp. · Jan 1992
LIPASE LINEARITY CONTROL
K913585 · Creative Laboratory Products, Inc. · Oct 1991
QUANTIMETRIX AMMONIA CONTROLS
K913346 · Quantimetrix Corp. · Sep 1991