# K123018: Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode (Ise) Module

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
- Decided: Apr 23, 2013 after 207 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931786 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933862: Ace (TM) Clin Chem Syst W/Opt Ion Select Electr (Ise), Schiapparelli Biosystems, Inc. (1993) Summary page 1.
- K113253: Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace Bun/Ureanitrogen Reagent, Alfa Wassermann Diagnostic Technologies, Inc. (2012)
- K930104: Ace Clinical Chemistry System, Schiapparelli Biosystems, Inc. (1993) Summary page 5.

## Cited in the summary but 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K123018
Methodology: https://510kreport.com/methodology