Cleared Traditional

K912733 - AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT

K912733 is an FDA 510(k) clearance for AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED)..., manufactured by Amersham Corp.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K912733 · Amersham Corp. · Chemistry device
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Jul 1991
Decision
32d
Days
Class 2
Risk

K912733 is an FDA 510(k) clearance for the AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on July 22, 1991 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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

FDA 510(k) Submission Details - K912733

510(k) Number K912733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1991
Decision Date July 22, 1991
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 218
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K912733.
DIAZO COLORIMETRY, BILIRUBIN
K914873 · Pointe Scientific, Inc., · Dec 1991
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
K913466 · Em Diagnostic Systems, Inc. · Oct 1991
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
K913307 · Em Diagnostic Systems, Inc. · Oct 1991
TRACE TOTAL/DIRECT BILIRUBIN REAGENT
K911866 · Trace Scientific , Ltd. · Jul 1991
TOTAL BILIRUBIN REAGENT SET
K910635 · Biochemical Trade, Inc. · May 1991
ROCHE REAGENT FOR TOTAL BILIRUBIN
K910591 · Roche Diagnostic Systems, Inc. · Apr 1991