PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS

K040280 · Roche Diagnostics Corp. · JJY · Mar 11, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040280
• Device Name: PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Precinorm PUC (Proteins in Urine/CSF) is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. The Precipath PUC (Proteins in Urine/CSF) is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

Device Story

Precinorm PUC and Precipath PUC are liquid, ready-to-use quality control materials consisting of buffered aqueous solutions with biological additives. They are formulated to represent normal and pathological analyte ranges for urine and CSF protein testing. Used in clinical laboratory settings by technicians or laboratory personnel to verify the performance of quantitative analytical methods. The healthcare provider compares the measured values of the control against the provided value sheet to assess the accuracy and precision of the test system. This monitoring ensures the reliability of patient diagnostic results.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed across seven external laboratories using five independent series per lab, with median values used as setpoints after outlier deletion.

Technological Characteristics

Buffered aqueous solution; liquid, ready-to-use format. Designed for use on Roche Hitachi and Cobas clinical analyzers. Stability: 4 weeks at 2-8 °C once opened.

Indications for Use

Indicated for use as quality control material to monitor accuracy and precision of quantitative laboratory methods for proteins in urine and cerebrospinal fluid (CSF). Prescription use only.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Roche Diagnostic Precinorm Protein Precipath Protein Controls (K981401)

Submission Summary (Full Text)

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

A. 510(k) Number:
k040280

B. Analyte:
Multi-analyte Controls assayed and unassayed (proteins in urine/csf)

C. Type of Test:
Not Applicable

D. Applicant:
ROCHE DIAGNOSTICS CORP.

E. Proprietary and Established Names:
Precinorm proteins in urine/csf and Precipath proteins in urine/csf controls

F. Regulatory Information:
1. Regulation section:
21CFR §862.1660 -Quality control material (assayed and unassayed).
2. Classification:
Class 1
3. Product Code:
JJY
4. Panel:
Chemistry (75)

G. Intended Use:
1. Indication(s) for use:
The Precinorm PUC (Proteins in Urine/CSF) is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

The Precipath PUC (Proteins in Urine/CSF) is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

2. Special condition for use statement(s):
Prescription use

3. Special instrument Requirements:
For use on the Roche Hitachi and Cobas family of analyzers.

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H. Device Description:
The Precinorm PUC and Precipath PUC controls consist of a buffered aqueous solution with biological materials added as required to obtain desired component levies in either the normal or pathological range. Values for constituent analytes are provided in product labeling.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Precinorm protein precipath protein controls
2. Predicate K number(s):
k981401
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Stability | Same | Unopened: 2-8 °C until expiration date
Opened: stable for 4 weeks at 2-8 °C |
| Format | Same | Liquid ready-for use |
| Range | Same | Adjusted to represent normal and pathological ranges |
| Differences | | |
| Item | Device | Predicate |
| Intended Use | For QC monitoring of specified quantitative methods | For QC monitoring of quantitative methods on both manual techniques and for assay on automated clinical analyzers |
| Matrix Analytes | Buffered aqueous solution
Albumin
Creatinine
Total Protein
Urine/CSF Protein | Stabilized human serum
Alph1-acid glycoprotein
Albumin
Alpha1-anitrypsin
Antistreptolysin O
C3c
C4
Ceruloplasmin
C-Reactive Protein
Ferritin
Haptoglobin
IgA
IgG
IgM |

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| | | Prealbumin
Total Protein
Transferrin |
| --- | --- | --- |

J. Standard/Guidance Document Referenced (if applicable):
None Referenced

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):
The value assignment takes place in seven external laboratories. Each laboratory runs 5 independent series. An independent series includes full calibration using a new calibrator vial and sample vial. After outlier deletion the median is used as setpoint. Controls which have to be assigned are used as samples. The master calibrator is used for calibration.

Along with value assignment, two additional samples are used for trend control. Both are processed control materials using the same or comparable matrix as the assigned control. If one of the trend controls is out of the defined ranges, a check of the reference standardization is initiated.

d. Detection limit:
Not Applicable

e. Analytical specificity:
Not Applicable

f. Assay cut-off:
Not Applicable

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
Not Applicable

3. Clinical studies:
a. Clinical sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable

4. Clinical cut-off:

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Not Applicable

5. Expected values/Reference range:

Not Applicable

**M. Conclusion:**

The information and data provided by ROCHE DIAGNOSTICS CORP. supports a Substantial Equivalence (SE) determination of Precinorm proteins in urine/csf and Precipath proteins in urine/csf controls to other multi-analyte controls, all kinds (assayed and unassayed) regulated under 21 CFR §862.1660 - Quality control material (assayed and unassayed).