ABX PENTRA URINE CAL

K071779 · Horiba Abx · JIX · Mar 5, 2008 · Clinical Chemistry

Device Facts

• Record ID: K071779
• Device Name: ABX PENTRA URINE CAL
• Applicant: Horiba Abx
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 5, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

This calibrator is intended for use on the ABX PENTRA 400 in association with the ABX Pentra Urinary Proteins CP reagent for the quantitative determination of total proteins in urine.

Device Story

ABX PENTRA Urine Cal is a single-level, aqueous, buffered calibrator solution derived from human and sheep sources; contains protein, albumin, a1-microglobulin, and Immunoglobulin G. Used in clinical chemistry laboratories to calibrate the ABX PENTRA Urinary Proteins CP assay on the Horiba ABX PENTRA 400 analyzer. Value assignment involves assaying new lots across multiple analyzers over 5 days; target values determined by median results if inter-analyzer deviation is <10%. Ensures accuracy of quantitative protein measurements in patient urine samples, aiding clinicians in diagnosing or monitoring renal function and protein-related pathologies.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (shelf life 12 months, open vial 4 weeks) and value assignment protocols (multi-analyzer testing over 5 days) met acceptance criteria. Traceability established to NIST SRM 927c.

Technological Characteristics

Liquid calibrator; buffered aqueous solution with chemical additives and biological materials. Designed for use on the ABX PENTRA 400 discrete photometric benchtop clinical chemistry analyzer. Stability: 12 months closed at 2-8°C; 4 weeks open at 2-8°C. Provided in 1 ml vials.

Indications for Use

Indicated for use as a calibrator for the quantitative measurement of urinary proteins on the Horiba ABX PENTRA 400 clinical chemistry analyzer.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Roche C.F.A.S.Proteins in Urine (k062319)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k071779

B. Purpose for Submission:
New device

C. Measurand:
Calibrator for urine protein

D. Type of Test:
Not applicable - calibrator

E. Applicant:
Horiba ABX

F. Proprietary and Established Names:
ABX PENTRA Urine Calibrator

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1150, Calibrator
2. Classification:
Class II
3. Product code:
JIX, Calibrator, Multi-analyte mixture
4. Panel:
Clinical Chemistry (75)

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H. Intended Use:

1. Intended use(s):

See Indications for Use below.

2. Indication(s) for use:

The ABX PENTRA Urine Cal is a calibrator for use in the calibration of the quantitative method: ABX PENTRA Urinary Proteins CP on Horiba ABX PENTRA 400 clinical chemistry analyzer.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

For use with the ABX Pentra 400

I. Device Description:

The ABX PENTRA Urine Cal is a single level human and sheep based, aqueous, buffered solution, containing protein, albumin, a1-microglobulin and Immunoglobulin G constituents.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Roche C.F.A.S.Proteins in Urine

2. Predicate K number(s):

k062319

3. Comparison with predicate:

| Item | Roche CFAS urine cal | ABX PENTRA urine cal |
| --- | --- | --- |
| Matrix | Liquid, ready to use | Same |
| Instrument | Roche analyzers | ABX PENTRA 400 |
| Constituents | Total protein, albumin, urine/csf protein, IGG | Total protein assayed Albumin, a1 microglobulin and IGG unassayed |
| Closed stability | 2-8°C until exp. date | 12 mos. at 2-8°C |
| Open stability | 4 weeks at 2-8°C | same |

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K. Standard/Guidance Document Referenced (if applicable):

FDA/CDRH Guidance for Industry: Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The calibrator is traceable to NIST SRM 927c

Shelf life stability was tested over a total period of 19 months. The recovery in protein content of the calibrator was assayed for 3 lots periodically over that period. The calibrator was stored within the defined temperature limits of 2-8°C. Results met the defined acceptance criteria and supported the claim for 12 month shelf life stability between 2-8°C.

Open vial stability was tested on 3 lots over a total period of 4 weeks. During this period, the open calibrator was stored at 4°C. Results met the defined acceptance criteria and supported the claim for 4 week open stability between 2-8°C.

The value assignment process consists of assaying new lots of calibrator on 6 ABX PENTRA 400 analyzers over 5 days. If the percent deviation between lowest and highest mean is less than 10%, then the target value is determined by the median of all results yielded from all analyzers.

d. Detection limit:

Not applicable

e. Analytical specificity:

3

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Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.