510(k) · Cleared
Recalled · Class II · 2015Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol 1 and 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seppim S.A.S. · CGA Glucose Oxidase, Glucose
Cleared on Dec 15, 2010 as substantially equivalent to K052007 (Horiba Abx, 2005) and 2 other predicates after a 294-day review. Its family tree reaches back 4 generations to 1994. It has been recalled 4 times.
- Decided
- Dec 15, 2010
- Review
- 294 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 4 generations to K933930 (1994). 16 ancestors in all, the oldest K801297 (1980). No later device cites it as a predicate yet.
- Root · 4 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 3 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 2 generations backK041122 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · Recalled
- 1 generation backK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
- This deviceK100525 Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems…Seppim S.A.S. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −3 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −2 | K041122 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2004 | 1 |
| −1 | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) | Horiba Abx | 2005 | 6 |
| 0 (this device) | K100525 | Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2… | Seppim S.A.S. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 |
|---|---|---|---|
| * | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Summary page 1…sification name Glucose test system (Sec.862.1345) Product code OGA - Glucose Oxidase, Glucose Predicate device ABX PENTRA GLUCOSE PAP CP (K052007) Device description The device for this submission is available as kit only. It consists of 1… | 2005 |
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 4…JIX- Calibrator, multi-analyte mixture Predicate device Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501) Device description ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on hu… | 2003 |
| * | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraSummary page 7…862.1660) Product code JJX- Multi-analyte controls - all kinds Predicate device Roche Diagnostics Precinorm U(K041227) Roche Diagnostics Precipath U(K041227) Device description ELITech Clinical Systems ELITROL I… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2015 | Class II | Z-0214-2016 | Under Investigation by firm | ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received. |
| Sep 22, 2015 | Class II | Z-0215-2016 | Under Investigation by firm | ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. No complaints were received. |
| Sep 22, 2015 | Class II | Z-0217-2016 | Under Investigation by firm | ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received. |
| Sep 22, 2015 | Class II | Z-0216-2016 | Under Investigation by firm | ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 8 other devices also cite its predicate K052007.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ELiTech Clinical Systems GLUCOSE PAP SL is intended for use with ELiTech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL 11for the quantitative in vitro diagnostic determination of glucose in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including…
Read the full statement (192 words)
ELiTech Clinical Systems GLUCOSE PAP SL is intended for use with ELiTech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL 11for the quantitative in vitro diagnostic determination of glucose in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.
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 the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL I isa multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELiTech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL 11is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100525 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100525: Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol 1 and 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100525
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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