510(k) · Cleared
ClearedNBIL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · MQM Bilirubin (Total And Unbound) In The Neonate Test System
Cleared on Sep 23, 1998 as substantially equivalent to K880743 (Abbott Laboratories, 1988) after a 15-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Sep 23, 1998
- Review
- 15 days
- Class
- Class I
- Product code
- MQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880743 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK880743 Abbott a-Gent Neonatal Bilirubin ReagentAbbott Laboratories · 1988
- This deviceK983134 NBILAbbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880743 | Abbott a-Gent Neonatal Bilirubin Reagent | Abbott Laboratories | 1988 | — |
| 0 (this device) | K983134 | NBIL | Abbott Laboratories | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K880743 | Abbott a-Gent Neonatal Bilirubin ReagentSummary page 1…ect for any hemoglobin present in the sample. Substantial Equivalence: The Neonatal Bilirubin assay is substantially equivalent to the A-GENT® Neonatal Bilirubin assay (K880743) on the ABBOTT SPECTRUM? Series II"™ System. Neonatal Bilirubin 510(k) Section 11 September 4, 1998 Page 1 NBil_5_V1.lwp 000001… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All MQM devicesMQM Bilirubin (Total And Unbound) In The Neonate Test System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQM
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MQM
Too few MQM 510(k)s in any year since 2007 to give a median.
Recalls per year · MQM
No recall names MQM since 2007.
Adverse event reports per year · MQM
2in 2025
MAUDE reports naming product code MQM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Neonatal Bilirubin assay is used for the quantitation of bilirubin in human neonate serum or plasma. Measurements of bilirubin (total and unbound) in newborn infants are used to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983134: NBIL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983134
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026