N/T PROTEIN CONTROL LC

K991704 · Dade Behring, Inc. · JJY · Jun 25, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991704
• Device Name: N/T PROTEIN CONTROL LC
• Applicant: Dade Behring, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

N/T Protein Control LC is intended for use as an assayed accuracy control for immunonephelometric determination of the proteins α--microglobulin in urine, IgA in CSF, IgG in CSF, transferrin in urine, albumin in urine and CSF, and total protein in urine and CSF using the Behring Nephelometer Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTimeSystem.

Device Story

N/T Protein Control LC is a lyophilized, multi-analyte quality control material derived from human urine and serum proteins, supplemented with polygeline, rabbit albumin, and preservatives. It serves as an assayed accuracy control for clinical laboratory testing. The device is used by laboratory professionals to monitor the performance and accuracy of immunonephelometric assays on Behring Nephelometer Systems and immunoturbidimetric assays on the TurbiTimeSystem. By providing known concentrations of specific proteins, the control allows clinicians to verify the reliability of patient test results for urine and CSF proteins. The device is stable for 24 months at 2-8°C in its original state and 14 days at 2-8°C after reconstitution.

Clinical Evidence

No clinical data. Performance characteristics were established via bench testing, specifically evaluating stability. The control was found stable for at least 24 months at +2° to +8° C in original packaging and at least 14 days at +2° to +8° C after reconstitution.

Technological Characteristics

Lyophilized control material composed of human urine and serum proteins, polygeline, rabbit albumin, and preservatives. Designed for use with immunonephelometry and immunoturbidimetry systems. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as an assayed accuracy control for laboratory personnel performing immunonephelometric or immunoturbidimetric determination of specific proteins (α-microglobulin, IgA, IgG, transferrin, 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 UY (K955858)

Submission Summary (Full Text)

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## 510(k) Summarv For N/T Protein Control LC

### 1. Manufacture's Name, Address, Telephone, and Contact Person, Date of Preparation:

| Manufacturer: | Dade Behring Marburg GmbH<br>Emil-von-Behring Str. 76<br>Marburg/Germany |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.<br>Glasgow Site<br>P.O. Box 6101<br>Newark, Delaware 19714<br>Attn: Rebecca S. Ayash<br>Tel: [phone] |
| Preparation date: | May 19, 1999 |

#### 2. Device Name/ Classification:

N/T Protein Control LC:

Quality Control Material (assayed)

Classification Number: Class I (862.1660)

#### 3. Identification of the Legally Marketed Device:

N/T Protein Control UY (K955858)

#### 4. Device Description:

N/T Protein Control LC is a lvophilized control prepared from human urine and serum proteins with polygeline, rabbit albumin, and preservative. It is intended to be used as an accuracy control for the determination of human proteins in urine and CSF by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.

#### 5. Device Intended Use:

N/T Protein Control LC is intended for use as an assayed accuracy control for immunonephelometric determination of the proteins & - microglobulin in urine, IgA in CSF, IgG in CSF, transferrin in urine, albumin in urine and CSF, and total protein in urine and CSF using the Behring Nephelometer Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTimeSystem.

#### 6. Medical device to which equivalence is claimed and comparison information:

There are a number of in vitro diagnostic products that are used as quality control material to monitor the accuracy of immunology procedures. One such product is the N/T Protein Control UY (K955858). The N/T Protein Control LC is substantially equivalent in intended use to the N/T Protein Control UY. The N/T Protein Control LC, like the N/T Protein Control UY, is a lyophilized, multi-analyte control with known concentrations of specific proteins for control of nephelometric and turbidometric procedures.

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#### 7. Device Performance Characteristics:

### Stability:

Stability was evaluated according to in-house protocols and the control was found to be stable for at least 24 months at +2° to +8° C, as originally packaged and for at least 14 days at +2° to +8° C, once reconstituted.

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JUN 25 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Ayash Manager, Regulatory Affairs, Biology Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714

K991704 Re: Trade Name: N/T Protein Control LC Regulatory Class: I Product Code: JJY Dated: May 19, 1999 Received: May 19, 1999

Dear Ms. Ayash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97): Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours.

Steven Putman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Dade Behring Inc. N/T Protein Control LC 510(k) Notification

# Indications for Use Statement

N/T Protein Control LC Device Name:

# Indications for Use:

N/T Protein Control LC is intended for use as an assayed accuracy control for immunonephelometric determination of the proteins α--microglobulin in urine, IgA in CSF, IgG in CSF, transferrin in urine, albumin in urine and CSF, and total protein in urine and CSF using the Behring Nephelometer Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTimeSystem.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) |
|----------------------|---------------------------------|
| | Division of Clinical Laboratory |
| 510(k) Number | K991704 |
| Prescription Use | Over-The-Counter-Use |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |