510(k) · Cleared
ClearedIL Synthesis--Addition of Bilirubin as a Measured Parameter for Neonate Whole Blood Samples
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · MQM Bilirubin (Total And Unbound) In The Neonate Test System
Cleared on May 6, 1998 as substantially equivalent to K832236 (Sigma Chemical Co., 1983) after a 76-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- May 6, 1998
- Review
- 76 days
- Class
- Class I
- Product code
- MQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K832236 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK832236 Sigma Procedure #550 Determ. BilirubSigma Chemical Co. · 1983
- This deviceK980646 IL Synthesis--Addition of Bilirubin as a Measured Parameter for…Instrumentation Laboratory CO · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832236 | Sigma Procedure #550 Determ. Bilirub | Sigma Chemical Co. | 1983 | — |
| 0 (this device) | K980646 | IL Synthesis--Addition of Bilirubin as a Measured Parameter for Neonate Whole… | Instrumentation Laboratory CO | 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 |
|---|---|---|---|
| * | K832236 | Sigma Procedure #550 Determ. BilirubSummary page 1…h Neonate Whole Blood Samples ' Classification name(s): 862.1113 Bilirubin (total and unbound) in the neonate test system Class I Identification of predicate devices: K832236 Sigma’s Bilirubin, Total and Direct Description of the device/intended use(s): The IL Synthesis™ is a family of fully automatic… | 1983 |
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 IL Synthesis™ is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers that was cleared for market by K963800. A new measured co-oximeter parameter is being added on the IL Synthesis™ for the semiquantitative determination of total bilirubin in whole blood from neonates. Elevated bilirubin levels in the blood of newborns is 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/K980646 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980646: IL Synthesis--Addition of Bilirubin as a Measured Parameter for Neonate Whole Blood Samples.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980646
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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