510(k) · Cleared
ClearedELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup · CFR Hexokinase, Glucose
Cleared on Sep 7, 2016 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) and 2 other predicates after a 261-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Sep 7, 2016
- Review
- 261 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K811832 (1981). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK811832 Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp. · 1981
- 2 generations backK992900 Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp. · 1999
- 1 generation backK041227 Modification to:Roche Diagnostics Precinorm Universal and Precipath…Roche Diagnostics Corp. · 2004
- This deviceK153644 ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems…Elitechgroup · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K811832 | Precinorm U & Precipath U Human Serum | Boehringer Mannheim Corp. | 1981 | — |
| −2 | K992900 | Precinorm Universal and Precipath Universal Control Sera | Roche Diagnostics Corp. | 1999 | — |
| −1 | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal… | Roche Diagnostics Corp. | 2004 | — |
| 0 (this device) | K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2… | Elitechgroup | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K951595 | Roche Cobas Integra Analyzer, Reagent CassettesSummary page 4…JJY Clinical Chemistry 21 CFR 826.1660 5. Predicate Device: K951595 Roche Diagnostics Cobas C111 Glucose HK Page… | 1995 |
| * | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraSummary page 8…and after a maintenance operation. Control Sera 1. Predicate Device Name: Roche Diagnostics Precinorm U and Precipath U 2. k041227 3. Comparison with predicate Similarities and Differences ELITech Cl… | 2004 |
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 9…) Page 5 of 13 Calibrator 1. Predicate Device Name: Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) 2. k033501 3. Comparison with predicate Similarities and Differences ELITec… | 2003 |
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?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 31 other devices also cite its predicate K951595.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases. ELITech Clinical Systems ELICAL 2 is a multi-parametric…
Read the full statement (113 words)
ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153644: ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153644
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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