OXALATE URINE CONTROLS (NORMAL AND ELEVATED)

K062521 · Thermo-Electron Corp. · JIT · Mar 16, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062521
• Device Name: OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
• Applicant: Thermo-Electron Corp.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Oxalate Normal and Elevated Controls are for use in the quality control of the Thermo Oxalate method for the quantitative determination of urine oxalate. The control is used for monitoring accuracy and precision on automated clinical chemistry analyzers and for manual operation. It is for in vitro diagnostic use only. The Oxalate Standard is intended for the calibration of Oxalate assays using the Thermo Oxalate Reagent. It is for in vitro diagnostic use only.

Device Story

Oxalate Urine Controls and Oxalate Standard function as in vitro diagnostic reagents; used in clinical laboratory settings by technicians or laboratory personnel. Controls monitor accuracy/precision of quantitative urine oxalate determination; Standard calibrates Thermo Oxalate Reagent assays. Used on automated clinical chemistry analyzers or manual platforms. Provides reference values for quality control and calibration; enables healthcare providers to verify assay performance; ensures reliable patient test results for oxalate levels.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria were reviewed and found acceptable. Traceability established to NIST SRM # 40h.

Technological Characteristics

In vitro diagnostic reagents (controls and standard) for quantitative urine oxalate determination. Designed for use with Thermo Oxalate Reagent on automated clinical chemistry analyzers or manual laboratory systems. Class II device (21 CFR 862.1150).

Indications for Use

Indicated for quality control and calibration of urine oxalate assays in clinical laboratory settings. No specific patient population or contraindications defined.

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.

Submission Summary (Full Text)

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

A. 510(k) Number:
k062521

B. Purpose for Submission:
New device

C. Measurand:
Calibrator and control materials for oxalate,

D. Type of Test:
Calibrator and control materials

E. Applicant:
Thermo Electron Corporation

F. Proprietary and Established Names:
Oxalate Urine Controls (Normal & Elevated)
Oxalate Standard

G. Regulatory Information:
1. Regulation section:
21 CFR §862. 1150, Calibrator
21 CFR §862. 1660, Quality Control Material
2. Classification:
Class II and Class I, respectively
3. Product Code:
JIT and JJW, respectively
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
See indications for use below
2. Indication(s) for use:
The Oxalate Normal and Elevated Controls are for use in the quality control
of the Thermo Oxalate method for the quantitative determination of urine

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oxalate. The control is used for monitoring accuracy and precision on automated clinical chemistry analyzers and for manual operation. It is for in vitro diagnostic use only.

The Oxalate Standard is intended for the calibration of Oxalate assays using the Thermo Oxalate Reagent. It is for in vitro diagnostic use only.

3. Special condition for use statement(s):
Prescription Use Only

4. Special instrument Requirements:
Roche Cobas Mira

I. Device Description:

The Oxalate Urine Controls (Normal & Elevated) are aqueous synthetic urine preparations, formulated for monitoring the accuracy and precision of urine oxalate assays.

The Oxalate Standard is prepared gravimetrically from a certified primary reference material, and is supplied as an aqueous preparation with preservative. The standard contains 0.50 mmol/L Oxalate.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Oxalate Urine Controls, Sigma Chemical Co.
Oxalate Standard (0.5 mmol/L)

2. Predicate K number(s):
k842366
k883525

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The Oxalate Urine Controls (Normal & Elevated) are for use in the quality control of the Thermo Oxalate method for the quantitative determination of urine oxalate. The control is used for monitoring accuracy and precision on automated clinical chemistry analyzers and for manual operation. It is for | It is designed for use as a control in the determination of Oxalate according to Trinity Biotech Procedure No. 591 |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | in vitro diagnostic use only.
The Oxalate Standard is intended for the calibration of Oxalate assays using the Thermo Oxalate Reagent. It is for in vitro diagnostic use only. | |
| Matrix | Lyophilized powder - reconstituted | Liquid |
| Storage | 2 to 8°C | 2 to 8°C |

K. Standard/Guidance Document Referenced (if applicable):
None were reference in the submission.

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 (controls, calibrators, or method):
The Thermo Oxalate Standard and control materials are prepared gravimetrically from an in-house primary standard that is traceable to NIST SRM # 40h. The target value for the standard is 0.5 mmol/L. Target values for the control materials are 0.3 mmol/L and 1.0 mmol/L. Values for the control materials are provided in the labeling for the Roche Cobas Mira.

Stability testing protocols and acceptance criteria were described and found to be acceptable. Accelerated stability testing was performed to support the expiration date. Real time studies are on going.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:

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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:
Target values for the control materials are provided in the labeling for the Roche Cobas Mira. The labeling includes a recommendation that each laboratory establish its own mean and acceptable range.

N. Proposed Labeling:
The labeling is sufficient and satisfies the requirement of 21 CFR part 809.10

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