Cleared Traditional

K792290 - TSH STANDARDS & DILUENT

K792290 is the FDA 510(k) clearance for TSH STANDARDS & DILUENT by Amersham Corp.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K792290 · Amersham Corp. · Chemistry device

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Dec 1979

Decision

23d

Days

Class 2

Risk

K792290 is an FDA 510(k) clearance for the TSH STANDARDS & DILUENT. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Amersham Corp. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amersham Corp. devices

Submission Details

510(k) Number	K792290 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 13, 1979
Decision Date	December 06, 1979
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

65d faster than avg

Panel avg: 88d · This submission: 23d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	JIT Calibrator, Secondary
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1150

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 - JIT Calibrator, Secondary

All 171

Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K792290.

CHOLESTEROL STANDARDS

K802823 · Mallinckrodt Critical Care · Dec 1980

SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT

K800770 · Sclavo, Inc. · Apr 1980

CALIBRATOR NO. 1 & 2, & WASH SOLUTION

K800220 · Fisher Scientific Co., LLC · Feb 1980

DUAL COMPONENT STANDARDS

K781423 · Abbott Laboratories · Aug 1978

T3 STANDARDS IN HUMAN SERUM

K781069 · Pcl-Ria, Inc. · Aug 1978

STANDARDS, HORMONE, THYROID STIMULATING

K781071 · Pcl-Ria, Inc. · Aug 1978

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K792290

Amersham Corp.

Mchenry, IL · US

Regulatory profile

94 submissions 94 cleared

100% clearance rate · Active in Chemistry

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Sourced from FDA 510(k) public files . Updated monthly.

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