Cleared Traditional

K925649 - NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY

K925649 is an FDA 510(k) clearance for NAT. SCREENING INSTITUTE MICRO-PLATE FR..., manufactured by Solarcare Technologies Corp,Inc.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K925649 · Solarcare Technologies Corp,Inc. · Chemistry device
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Mar 1993
Decision
112d
Days
Class 2
Risk

K925649 is an FDA 510(k) clearance for the NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 1, 1993 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 Solarcare Technologies Corp,Inc. devices

FDA 510(k) Submission Details - K925649

510(k) Number K925649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date March 01, 1993
Days to Decision 112 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
24d slower than avg
Panel avg: 88d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 Chemistry devices follow this clearance model.

Regulatory Peers - CEC Radioimmunoassay, Free Thyroxine

All 79
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K925649.
IMMULITE FREE T4
K931704 · Diagnostic Products Corp. · Aug 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110 · Bio-Rad · May 1993
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM
K925842 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1993
ACCESS(R) FREE T4 ASSAY
K925913 · Bio-Rad Laboratories, Inc. · Jan 1993
VIDAS FREE THYROXINE(FT4) ASSAY
K925177 · Biomerieux Vitek, Inc. · Nov 1992
VISTA FREE THYROXINE ASSAY
K923572 · Syva Co. · Nov 1992