# K103615: Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.V. Reagent,Urine Standard

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
- Decided: Sep 8, 2011 after 273 days
- Product code: CDN (Urease, Photometric, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K875285 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954000: Roche Reagent for Bun, Roche Diagnostic Systems, Inc. (1995) Summary page 2.
- K896224: Cobas Ready Calcium Reagent, Roche Diagnostic Systems, Inc. (1990) Summary page 2.
- K883962: Roche Reagent for Inorganic Phosphorus, Roche Diagnostic Systems, Inc. (1988) Summary page 2.
- K901229: Chem 1 Clinical Analyzer (Method Urine Creatinine), Technicon Instruments Corp. (1990) Summary page 2.
- K875285: Multi-Chemistry Linearity Standard, Verichem Laboratories, Inc. (1988) Summary page 2.

## Recalls of this device
- Oct 10, 2012 · Class II · Z-0743-2013: Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.

## Indications for use
The ACE Urea Nitrogen Reagent is intended for the quantitative determination of urea nitrogen concentration in urine using the ACE and ACE Alera Clinical Chemistry Systems. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium in urine using the ACE and ACE Alera Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Creatinine Reagent is intended for the quantitative determination of creatinine in urine using the ACE and ACE Alera Clinical Chemistry Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in urine using the ACE and ACE Alera Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Alfa Wassermann Diagnostic Technologies, LLC ACE Urine Standard is intended for the calibration of quantitative urine reagents on Alfa Wassermann Clinical Chemistry Systems. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K103615
Methodology: https://510kreport.com/methodology