Cleared Traditional

K791141 - BILIRUBIN CALIBRATOR CONTROL

K791141 is an FDA 510(k) clearance for BILIRUBIN CALIBRATOR CONTROL, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K791141 · Beckman Instruments, Inc. · Chemistry device
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Aug 1979
Decision
53d
Days
Class 1
Risk

K791141 is an FDA 510(k) clearance for the BILIRUBIN CALIBRATOR CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1979 after a review of 53 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K791141

510(k) Number K791141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1979
Decision Date August 10, 1979
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
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 381
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K791141.
CODE QAS.105 PROLACTIN CONTROL SERA
K800708 · Amersham Corp. · Apr 1980
PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
K800035 · Miles Laboratories, Inc. · Jan 1980
CK-MB (CREATINE KINASE-MB) RIA CONTROL
K792524 · Mallinckrodt Critical Care · Jan 1980
NORMAL PROTEIN ELECTROPHORESIS CONTROL
K791029 · Beckman Instruments, Inc. · Jul 1979
ABNORMAL PROTEIN ELECTROPHORESIS CONTROL
K791031 · Beckman Instruments, Inc. · Jul 1979
DUPONT ACA CKMB VERIFIERS
K790376 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1979