Cleared Traditional

K905280 - BIOTROL BILIRUBIN C & T CONTROL

K905280 is the FDA 510(k) clearance for BIOTROL BILIRUBIN C & T CONTROL by Biotrol, USA, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K905280 · Biotrol, USA, Inc. · Chemistry device

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Feb 1991

Decision

73d

Days

Class 1

Risk

K905280 is an FDA 510(k) clearance for the BIOTROL BILIRUBIN C & T CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Biotrol, USA, Inc. (Westchester, US). The FDA issued a Cleared decision on February 4, 1991 after a review of 73 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number	K905280 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 23, 1990
Decision Date	February 04, 1991
Days to Decision	73 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

15d faster than avg

Panel avg: 88d · This submission: 73d

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 372

Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K905280.

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I

K911176 · Analytical Control Systems, Inc. · May 1991

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II

K911177 · Analytical Control Systems, Inc. · May 1991

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III

K911178 · Analytical Control Systems, Inc. · May 1991

DUPONT DRUG CALIBRATOR-A

K904306 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990

PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF

K902569 · Boehringer Mannheim Corp. · Aug 1990

CHEM-CHEX-ALT

K903147 · Streck Laboratories, Inc. · Aug 1990

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 K905280

Biotrol, USA, Inc.

Westchester, PA · US

ALLAN C MURPHY

Regulatory profile

46 submissions 46 cleared

100% clearance rate · Active in Chemistry

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

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