Product Code: MQM FDA class 1 21 CFR 862.1113

Bilirubin (Total And Unbound) In The Neonate Test System

Clinical Chemistry

The Bilirubin (Total and Unbound) in the Neonate Test System is a clinical chemistry in vitro diagnostic device used to measure total and unbound bilirubin levels in neonatal blood, enabling the assessment and management of neonatal hyperbilirubinemia (jaundice). Classified as FDA Class 1 under 21 CFR 862.1113 in the Clinical Chemistry specialty, it requires 510(k) notification and is eligible for third-party review. The product code is MQM.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code MQM in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: MQM
Device Class: FDA class 1
Regulation Number: 862.1113
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K170882	ABL90 FLEX, ABL90 FLEX PLUS	Apr 28, 2017	Substantially Equivalent	Radiometer Medical Aps
K133175	DRAEGER JAUNDICE METER JM-105	Nov 13, 2014	Substantially Equivalent	Draeger Medical Systems, Inc.
K132691	ABL90 FLEX	Nov 13, 2014	Substantially Equivalent	Radiometer Medical Aps
K110277	RAPIDPOINT 405 NEONATAL BILIRUBIN	Aug 15, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics
K073537	NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265	Jun 27, 2008	Substantially Equivalent	Siemens Medical Solutions Diagnostics
K042522	JAUNDICE METER, MODEL JM 103	Jul 06, 2005	Substantially Equivalent	Draeger Medical Infant Care, Inc.
K040174	BILIRUBIN ASSAY ON THE OMNI S ANALYZER	May 14, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K021622	HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103	Apr 01, 2003	Substantially Equivalent	Hill-Rom Air-Shields
K001687	COLORMATE TLC BILITEST SYSTEM	Sep 13, 2001	Substantially Equivalent	Chromatics Color Sciences Intl., Inc.
K010052	RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER	Mar 19, 2001	Substantially Equivalent	Respironics, Inc.
K994438	BILICHEK NON-INVASIVE BILIRUBIN ANALYZER	Feb 04, 2000	Substantially Equivalent	Spectrx, Inc.
K983071	BILICHEK NON-INVASIVE BILIRUBIN ANALYZER	Mar 04, 1999	Substantially Equivalent	Respironics, Inc.
K983134	NBIL	Sep 23, 1998	Substantially Equivalent	Abbott Laboratories
K972309	JM-102 JAUNDICE METER	Sep 22, 1998	Substantially Equivalent	Air-Shields, Inc.
K980646	IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES	May 06, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K964590	COLORMATE III	Jul 24, 1997	Substantially Equivalent	Chromatics Color Sciences Intl., Inc.
K922770	UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311	Aug 18, 1992	Substantially Equivalent	Leica, Inc.