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

Intended 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)

{0}------------------------------------------------

K032237

Dade Rehring Inc N/T Protein Control LC 510(k) Notification-Modification

SEP - 5 2003

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

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

Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany Dade Behring Inc. Contact Information: Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn:Kathleen Dray-Lyons Tel: [phone] Preparation date: July 18, 2003

#### 2. Device Name/ Classification:

N/T Protein Control LC: Quality Control Material (assaved)

Classification Number: Class I (862.1660)

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

N/T Protein Control LC (K991704)

#### 4. Device Description:

N/T Protein Control LC is a lyophilized 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 BN™ Systems and by immunoturbidimetry with the TurbiTimeSystem.

- 5. Device Intended 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 aqmicroglobulin 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.

- 6. Medical device to which equivalence is claimed and comparison information: The modified N/T Protein Control SL is substantially equivalent in intended use to N/T Protein Control LC currently marketed (K991704). The modified N/T Protein Control LC, like the current N/T Protein Control LC is intended to be used as quality control material to monitor the accuracy and precision of human urine and CSF protein assays on BN™ Systems and the TurbiTimeSystem

{1}------------------------------------------------

#### 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 +2º to +8º C, once reconstituted.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the symbol. The logo is black and white.

SEP - 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring Inc. P. O. Box 6101 Newark, DE 19714

Re: k032237

Trade/Device Name: N/T Protein Control LC Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 18, 2003 Received: July 21, 2003

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

k) Notification-Modification

# Indications for Use Statement

Device Name: N/T Protein Control LC

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

A.P. Reese for T.J. O'leary
(Division Signee)

Division of Clinical Laboratory Devices

510(k) Number_1_03-2237