CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF

K040264 · Roche Diagnostics Corp. · JIX · Apr 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040264
• Device Name: CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

C.f.a.s. (Calibrator for automated systems) PUC (Proteins in Urine/CSF) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Device Story

C.f.a.s. PUC is a liquid, single-level calibrator; buffered aqueous matrix containing human and ovine serum components. Used in clinical chemistry laboratories to calibrate Roche analyzers for albumin, total protein, and U/CSF protein assays. Provides known target values for instrument calibration; ensures accuracy of quantitative patient sample measurements. Operates via immunoturbidimetric or turbidimetric detection methods on compatible Roche/Hitachi or Cobas Integra systems.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid, single-level calibrator; buffered aqueous matrix with human and ovine serum components. Traceable to CRM 470 (albumin) and NIST bovine serum albumin (total/U/CSF protein). Designed for use on Roche/Hitachi and Cobas Integra clinical chemistry analyzers.

Indications for Use

Indicated for use as a calibrator for quantitative Roche clinical chemistry assays measuring albumin, total protein, and U/CSF protein on Roche/Hitachi and Cobas Integra systems.

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 Diagnostic Calibrator for Automated Systems (C.f.a.s.) Proteins (K011226)

Submission Summary (Full Text)

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

A. 510(k) Number:
K040264

B. Analyte:
Albumin, Total Protein, Urine/CSF (U/CSF) Protein

C. Type of Test:
Calibrator, Multi-Analyte Mixture

D. Applicant:
Roche Diagnostics

E. Proprietary and Established Names:
Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC)

F. Regulatory Information:
1. Regulation section:
21 CFR §862.1150
2. Classification:
Class II
3. Product Code:
JIX
4. Panel:
Clinical Chemistry (75)

G. Intended Use:
1. Indication(s) for use:
"C.f.a.s. (Calibrator for automated systems) PUC (Proteins in Urine/CSF) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet."
2. Special condition for use statement(s):
None noted.
3. Special instrument Requirements:
Roche/Hitachi systems (for albumin and U/CSF protein) and Cobas Integra (for total U/CSF protein)

H. Device Description:
C.f.a.s. PUC is a liquid single-level calibrator consisting of a buffered aqueous matrix with added calibrator components to ensure optimal concentration. Albumin is detected immunoturbidimetrically, while total protein and U/CSF protein are detected turbidimetrically.

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# I. Substantial Equivalence Information:

1. Predicate device name(s):
Calibrator for Automated Systems (C.f.a.s.) Proteins
2. Predicate K number(s):
K011226
3. Comparison with predicate:
Both devices are liquid, single-level calibrators. They have the same intended use and stability. They contain different analytes, and the predicate is based on stabilized human serum while the C.f.a.s. PUC is based on a buffered aqueous solution containing both human and ovine serum components.

# J. Standard/Guidance Document Referenced (if applicable):
See L.1.c below.

# K. Test Principle:
Not applicable.

# L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not applicable.
b. Linearity/assay reportable range:
Not applicable.
c. Traceability (controls, calibrators, or method):
Traceability: The sponsor maintains a set of master calibrators with albumin levels traceable to European Communities' CRM 470, and total protein and U/CSF protein levels traceable to a NIST primary bovine serum albumin standard.

Value Assignment: Seven external laboratories run five independent series that includes full calibration with a master calibrator and uses calibrators needing assignment as sample vials. Following outlier detection, the median is assigned as the target value.

Stability: Both real-time stability studies (C.f.a.s.PUC stored at 2-8°C for 18 months) and an accelerated stability study (C.f.a.s. PUC stored at 35°C for 14 days) support a claim that unopened C.f.a.s. PUC is stable for 18 months. Open-vial stability studies support a claim that C.f.a.s. PUC is stable up to 4 weeks at 4°C. In all studies the acceptance criteria was a mean recovery of 90-110% of the reference (i.e. Day 0) material that was stored at -80°C.

d. Detection limit:
Not applicable.

e. Analytical specificity:
Not applicable.

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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:

Values of One Representative Lot

| | Calibration Value (mg/L) | |
| --- | --- | --- |
| Analyte | HITACHI Systems | COBAS Integra |
| Albumin | 441 | N/A |
| Total Protein | N/A | 2080 |
| U/CSF Protein | 2080 | N/A |

# M. Conclusion:

I recommend that the Calibrator for Automated Systems Proteins in Urine/CSF (C.f.a.s. PUC) be found substantially equivalent to the predicate.