MQM · Bilirubin (Total And Unbound) In The Neonate Test System
Clinical Chemistry · 21 CFR 862.1113 · Class 1
Overview
| Product Code | MQM |
|---|---|
| Device Name | Bilirubin (Total And Unbound) In The Neonate Test System |
| Regulation | 21 CFR 862.1113 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
Classification Rationale
Class I.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170882 | ABL90 FLEX, ABL90 FLEX PLUS | Radiometer Medical Aps | Apr 28, 2017 | SESE |
| K133175 | DRAEGER JAUNDICE METER JM-105 | Draeger Medical Systems, Inc. | Nov 13, 2014 | SESE |
| K132691 | ABL90 FLEX | Radiometer Medical Aps | Nov 13, 2014 | SESE |
| K110277 | RAPIDPOINT 405 NEONATAL BILIRUBIN | Siemens Healthcare Diagnostics | Aug 15, 2011 | SESE |
| K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 | Siemens Medical Solutions Diagnostics | Jun 27, 2008 | SESE |
| K042522 | JAUNDICE METER, MODEL JM 103 | Draeger Medical Infant Care, Inc. | Jul 6, 2005 | SESE |
| K040174 | BILIRUBIN ASSAY ON THE OMNI S ANALYZER | Roche Diagnostics Corp. | May 14, 2004 | SESE |
| K021622 | HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 | Hill-Rom Air-Shields | Apr 1, 2003 | SESE |
| K001687 | COLORMATE TLC BILITEST SYSTEM | Chromatics Color Sciences Intl., Inc. | Sep 13, 2001 | SESE |
| K010052 | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER | Respironics, Inc. | Mar 19, 2001 | SESE |
| K994438 | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER | Spectrx, Inc. | Feb 4, 2000 | SESE |
| K983071 | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER | Respironics, Inc. | Mar 4, 1999 | SESE |
| K983134 | NBIL | Abbott Laboratories | Sep 23, 1998 | SESE |
| K972309 | JM-102 JAUNDICE METER | Air-Shields, Inc. | Sep 22, 1998 | SESE |
| K980646 | IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES | Instrumentation Laboratory CO | May 6, 1998 | SESE |
| K964590 | COLORMATE III | Chromatics Color Sciences Intl., Inc. | Jul 24, 1997 | SESE |
| K922770 | UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 | Leica, Inc. | Aug 18, 1992 | SESE |
Top Applicants
- Chromatics Color Sciences Intl., Inc. — 2 clearances
- Radiometer Medical Aps — 2 clearances
- Respironics, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
- Air-Shields, Inc. — 1 clearance
