Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1113](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1113) → MQM — Bilirubin (Total And Unbound) In The Neonate Test System

# MQM · Bilirubin (Total And Unbound) In The Neonate Test System

_Clinical Chemistry · 21 CFR 862.1113 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM

## Overview

- **Product Code:** MQM
- **Device Name:** Bilirubin (Total And Unbound) In The Neonate Test System
- **Regulation:** [21 CFR 862.1113](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1113)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K170882.md) | ABL90 FLEX, ABL90 FLEX PLUS | Radiometer Medical Aps | Apr 28, 2017 | SESE |
| [K133175](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K133175.md) | DRAEGER JAUNDICE METER JM-105 | Draeger Medical Systems, Inc. | Nov 13, 2014 | SESE |
| [K132691](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K132691.md) | ABL90 FLEX | Radiometer Medical Aps | Nov 13, 2014 | SESE |
| [K110277](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K110277.md) | RAPIDPOINT 405 NEONATAL BILIRUBIN | Siemens Healthcare Diagnostics | Aug 15, 2011 | SESE |
| [K073537](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K073537.md) | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 | Siemens Medical Solutions Diagnostics | Jun 27, 2008 | SESE |
| [K042522](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K042522.md) | JAUNDICE METER, MODEL JM 103 | Draeger Medical Infant Care, Inc. | Jul 6, 2005 | SESE |
| [K040174](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K040174.md) | BILIRUBIN ASSAY ON THE OMNI S ANALYZER | Roche Diagnostics Corp. | May 14, 2004 | SESE |
| [K021622](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K021622.md) | HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 | Hill-Rom Air-Shields | Apr 1, 2003 | SESE |
| [K001687](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K001687.md) | COLORMATE TLC BILITEST SYSTEM | Chromatics Color Sciences Intl., Inc. | Sep 13, 2001 | SESE |
| [K010052](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K010052.md) | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER | Respironics, Inc. | Mar 19, 2001 | SESE |
| [K994438](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K994438.md) | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER | Spectrx, Inc. | Feb 4, 2000 | SESE |
| [K983071](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K983071.md) | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER | Respironics, Inc. | Mar 4, 1999 | SESE |
| [K983134](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K983134.md) | NBIL | Abbott Laboratories | Sep 23, 1998 | SESE |
| [K972309](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K972309.md) | JM-102 JAUNDICE METER | Air-Shields, Inc. | Sep 22, 1998 | SESE |
| [K980646](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K980646.md) | IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES | Instrumentation Laboratory CO | May 6, 1998 | SESE |
| [K964590](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K964590.md) | COLORMATE III | Chromatics Color Sciences Intl., Inc. | Jul 24, 1997 | SESE |
| [K922770](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM/K922770.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MQM)

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