# K113435: Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann
- Decided: Jul 2, 2012 after 224 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931786 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931786: Ace Clinical Chemistry  System, Schiapparelli Biosystems, Inc. (1993) Summary page 2.

## Most influential descendants
- K122302: Ace Magnesium Regent (2012), 0 descendants of its own

## Indications for use
The ACE Carbon Dioxide (C0 2 -LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum using the ACE Axcel Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Direct Bilimubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hemnatological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilimubin, an organic compound formed during the normal and abnonmal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hernatological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K113435
Methodology: https://510kreport.com/methodology