# K070249: Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/H

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Apr 26, 2007 after 90 days
- Product code: CIC (Cresolphthalein Complexone, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- 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: 2 generations back to K971954 (1997). 6 ancestors in all.
11 later devices descend from it; 6 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896224: Cobas Ready Calcium Reagent, Roche Diagnostic Systems, Inc. (1990) Summary page 2.
- K941837: Roche Reagent for Creatinine, Roche Diagnostic Systems, Inc. (1994) Summary page 2.
- K883962: Roche Reagent for Inorganic Phosphorus, Roche Diagnostic Systems, Inc. (1988) Summary page 2.
- K972297: Amylase-Incorporating Dynamic Stabilization Technology - (DST), Trace America, Inc. (1997) Summary page 2.
- K020817: Liquichek Urine Chemistry Control, Bio-Rad Laboratories, Inc. (2002) Summary page 2.

## Most influential descendants
- K070146: Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP (2007), 3 descendants of its own
- K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont (2013), 2 descendants of its own
- K081276: Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H (2008), 2 descendants of its own
- K110530: Abx Pentra Creatinine 120 CP; Abx Pentra Multical;  Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control (2012), 1 descendant of its own
- K110137: Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P Control, and Abx Pentra Urin (2011), 1 descendant of its own

## Recalls of this device
- Sep 6, 2013 · Class III · Z-2280-2013: HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.

## Indications for use
ABX PENTRA Calcium CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). ABX PENTRA Creatinine CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jafft method). 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. ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. ABX PENTRA Amylase CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of the activity of the enzyme arnylase in human serum, plasma and urine based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

Source page: https://510kreport.com/device/K070249
Methodology: https://510kreport.com/methodology