N/T PROTEIN CONTROL

K032237 · Dade Behring, Inc. · JJY · Sep 5, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032237
• Device Name: N/T PROTEIN CONTROL
• Applicant: Dade Behring, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

N/T Protein Control LC is intended for use as an assayed accuracy and precision control for immunochemical determination of IgA, IgG and IgM in CSF, transferrin and a - microglobulin in urine, albumin and total protein in urine and CSF using the BN™ Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTime System.

Device Story

N/T Protein Control LC is a lyophilized, multi-analyte quality control material derived from human urine, polygeline, and rabbit albumin. It serves as an assayed accuracy and precision control for immunochemical protein determination in urine and CSF samples. Used in clinical laboratory settings, the control is processed on BN Systems (nephelometry) and TurbiTime System (turbidimetry). Healthcare providers compare measured values against provided assigned values to verify instrument performance and assay accuracy. The device benefits patients by ensuring the reliability of diagnostic protein testing.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized multi-analyte control; matrix includes human urine, polygeline, rabbit albumin, and preservative. Analyte calibration uses CRM 470 (RPPHS lot 5). Compatible with BN Systems (nephelometry) and TurbiTime System (turbidimetry).

Indications for Use

Indicated for use as an assayed accuracy and precision control for immunochemical determination of specific proteins (IgA, IgG, IgM, transferrin, a-microglobulin, albumin, total protein) in human urine and cerebrospinal fluid (CSF) samples.

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

• N/T Protein Control LC (K991704)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510 (k) Number: K032237
B. Analyte: N/T Protein Control LC
C. Type of Test: Assayed Quality Control Material
D. Applicant: Dade Behring Inc.
P.O. Box 6101
Newark, Delaware 19714
E. Proprietary and Established Names: N/T Protein Control LC

F. Regulatory Information:
1. Regulation section: 862.1660
2. Classification: Class I
3. Product Code: JJY
4. Panel: Chemistry (75)

G. Intended Use:
1. Indication for use: N/T Protein Control LC is intended for use as an assayed Accuracy and Precision Control for immunochemical determination of IgA, IgG and IgM in CSF, transferrin and Alpha-1-microglobulin in urine, albumin and total protein in urine and CSF using the BN™ Systems and also for IgG in CSF and albumin in urine and CSF, using TurbiTime System.
2. Special conditions for use: NA
3. Special Instrument Requirements: For use by nephlometry with BN™ Systems and turbidimetry with Turbi Time System.

H. Device description:

N/T Protein is a lyophilized, multi-analyte control with known concentrations of specific proteins prepared from human urine with polygeline, rabbit albumin and preservative. It is intended to be used as an assayed accuracy and precision control for immunochemical determination of human proteins in urine and CSF by immunonephlometry with BN Systems and Immunoturbidimetry with the Turbi Time System.

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I. Substantial Equivalence Information

1. Predicate Device Name (s): N/T Protein Control LC
2. Predicate K number: K991704

3. Comparison with Predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use: | Same as the predicate | |
| Matrix: | Same as the predicate | Urine and serum proteins of human origin with Polygeline, rabbit albumin and preservative |
| Analytes | Alpha -1- Microglobulin, transferrin, albumin, total protein
CSF: IgA, IgG, IgM, Albumin | Alpha -1- Microglobulin, transferrin, albumin, total protein
CSF: IgA, IgG, Albumin |
| Form: | Lyophilized | Lyophilized |
| Instruments used: | BN System and TurbiTime System | BN System and TurbiTime System |
| Differences | | |
| Item | Device | Predicate |
| analytes | IgM in CSF | |

J. Standards used: Commercially available standard preparation RPPHS lot 5 (CRM 470) for IgG, IgA, IgM, Albumin, Transferrin are used for calibration.

Guidance Document Referenced: None

K. Test Principle: Assayed Control

L. 1. Performance Characteristics: Not applicable

2. Comparison studies: Not applicable
3. Clinical studies: Not applicable
4. Clinical cut-off - not applicable
5. Expected values -not applicable

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Assigned values are given in a table for one lot for BN system

M. Conclusion:

Dade Behring’s N/T Protein Control LC, assayed quality control material (K032237), is substantially equivalent to Dade Behring’s N/T Protein control, assayed quality control material which was previously cleared (K991704) by FDA. The only difference is the current N/T Protein control includes a new analyte-IgM in addition to IgG and IgA.