Cleared Traditional

CODE QAS.105 PROLACTIN CONTROL SERA (K800708) - FDA 510(k) Clearance

Class I Chemistry device.

K800708 · Amersham Corp. · Chemistry device
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Apr 1980
Decision
16d
Days
Class 1
Risk

K800708 is an FDA 510(k) clearance for the CODE QAS.105 PROLACTIN CONTROL SERA. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Amersham Corp. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980 after a review of 16 days - a notably fast clearance cycle.

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: 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 K800708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1980
Decision Date April 16, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 195
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K800708.
HELENA VMA-SMC CONTROL
K811912 · Helena Laboratories · Jul 1981
PRECINORM U & PRECIPATH U HUMAN SERUM
K811832 · Boehringer Mannheim Corp. · Jul 1981
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
K802068 · Beckman Instruments, Inc. · Oct 1980
PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
K800035 · Miles Laboratories, Inc. · Jan 1980
BILIRUBIN CALIBRATOR CONTROL
K791141 · Beckman Instruments, Inc. · Aug 1979
NORMAL PROTEIN ELECTROPHORESIS CONTROL
K791029 · Beckman Instruments, Inc. · Jul 1979