Product Code: JFM FDA class 2 21 CFR 862.1110

Enzymatic Method, Bilirubin

Clinical Chemistry

Enzymatic Method for Bilirubin is a clinical chemistry test system that uses enzymatic reactions to measure bilirubin concentration in serum or plasma, used in the diagnosis and monitoring of liver disease, hemolytic disorders, and neonatal jaundice. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is JFM, regulated under 21 CFR 862.1110, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: JFM
Device Class: FDA class 2
Regulation Number: 862.1110
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 11 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K170065	ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)	Mar 09, 2017	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K152343	Direct Bilirubin	Feb 16, 2016	Substantially Equivalent	Randox Laboratories Limited
K152344	Total Bilirubin	Jan 28, 2016	Substantially Equivalent	Randox Laboratories Limited
K063845	ADVIA CHEMISTRY TOTAL BILIRUBIN_2	Dec 07, 2007	Substantially Equivalent	Bayer Healthcare, LLC
K053132	WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791	Dec 30, 2005	Substantially Equivalent	Wako Chemicals USA, Inc.
K053131	WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191	Dec 30, 2005	Substantially Equivalent	Wako Chemicals USA, Inc.
K053090	DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR	Dec 16, 2005	Substantially Equivalent	Beckman Coulter, Inc.
K050266	DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR	Jun 30, 2005	Substantially Equivalent	Stanbio Laboratory
K970985	WAKO TOTAL BILIRUBIN V	Apr 21, 1997	Substantially Equivalent	Wako Chemicals USA, Inc.
K904660	ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14	Nov 20, 1990	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K843174	DRI-STAT ENZYMATIC BILIRUBIN TEST KIT	Sep 14, 1984	Substantially Equivalent	Beckman Instruments, Inc.