510(k) · Cleared
ClearedPrestige 24I; Biolis 24I; MGC 240
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tokyo Boeki Medisys, Inc. · CFR Hexokinase, Glucose
Cleared on Dec 1, 2011 as substantially equivalent to K904219 (Beckman, 1990) and 1 other predicate after a 365-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Dec 1, 2011
- Review
- 365 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K802810 (1980). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK802810 Hexokinase, GlucoseBeckman Instruments, Inc. · 1980
- This deviceK103531 Prestige 24I; Biolis 24I; MGC 240Tokyo Boeki Medisys, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802810 | Hexokinase, Glucose | Beckman Instruments, Inc. | 1980 | — |
| 0 (this device) | K103531 | Prestige 24I; Biolis 24I; MGC 240 | Tokyo Boeki Medisys, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
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 CFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K904219 | Synchron CX 7 Clinical AnalyzerSummary page 2…, and idiopathic glycemia, and of the pancreatic islet cell carcinoma. Substantial Equivalence: Substantial equivalence has been demonstrated between the Beckman CX-7 (K904219) and the Biolis 24i. These analyzers are calibrated with known concentration calibrator material and both measure specific concen… | 1990 |
| * | K802810 | Hexokinase, GlucoseSummary page 3…Glucose hexokinase 510(k): k802810 Intended use Quantitative determination of Quantitative determination of… | 1980 |
| † | K070207 | Multi-Analyte Chemistry Calibrator | 2007 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K904219.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, 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 | 1 | — | 0 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Biolis 24i Clinical Chemistry Analyzer is a discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. The Biolis 24i analyzer with glucose hexokinase assay is…
Read the full statement (100 words)
The Biolis 24i Clinical Chemistry Analyzer is a discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose.
The Biolis 24i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia; and idiopathic glycemnia, and of the pancreatic isle cell carcinoma.
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/K103531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103531: Prestige 24I; Biolis 24I; MGC 240.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103531
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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