510(k) · Cleared
ClearedAce Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode (Ise) Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann Diagnostic Technologies, Inc. · CFR Hexokinase, Glucose
Cleared on Apr 23, 2013 as substantially equivalent to K933862 (Schiapparelli Biosystems, Inc., 1993) and 2 other predicates after a 207-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Apr 23, 2013
- Review
- 207 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K931786 (1993). 4 ancestors in all, the oldest K930104 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
- 1 generation backK113253 Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
- This deviceK123018 Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion…Alfa Wassermann Diagnostic Technologies, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931786 | Ace Clinical Chemistry System | Schiapparelli Biosystems, Inc. | 1993 | — |
| −1 | K113253 | Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein… | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
| 0 (this device) | K123018 | Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective… | Alfa Wassermann Diagnostic Technologies, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K930140 | ACE plus ISE/Clinical Chemistry System Reagents Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…te Manufacturer for reagent system predicates: Devices: Alfa Wassermann ACE plus ISE/Clinical ChemistrV System ___________ACE Reagents (K930 140, K933862) Device The ACE Alera Clinical Chemistry System is an automated, discrete, bench-top, Descript… | |
| * | K933862 | Ace (TM) Clin Chem Syst W/Opt Ion Select Electr (Ise)Summary page 1…Manufacturer for reagent system predicates: Devices: Alfa Wassermann ACE plus ISE/Clinical ChemistrV System ___________ACE Reagents (K930 140, K933862) Device The ACE Alera Clinical Chemistry System is an automated, discrete, bench-top, Descriptions:… | 1993 |
| * | K113253 | Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace… | 2012 |
| * | K930104 | Ace Clinical Chemistry SystemSummary page 5…ities and differences: GLUCOSE Candidate Device Predicate Device k930 104 (ACE Glucose Reagent) Intended For the quantitative meas… | 1993 |
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 20 years and passes through 2 companies; a new generation was cleared every 18.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ACE Alera Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative measurement of genera! chemistry assays, such as glucose, sodium, potassium, and chloride, for clinical use in physician office laboratories or clinical laboratories. * Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes…
Read the full statement (327 words)
The ACE Alera Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative measurement of genera! chemistry assays, such as glucose, sodium, potassium, and chloride, for clinical use in physician office laboratories or clinical laboratories.
* Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
* Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
* Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
* Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
ACE Glucose Reagent is intended for the quantitative determination of glucose in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE Ion Selective Electrode (ISE) module on the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems is used to measure concentrations of sodium, potassium, and chloride in undiluted serum and lithium heparin plasma.
* Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
* Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
* Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
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/K123018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123018: Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode (Ise) Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123018
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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