MODIFICATION OF N/T PROTEIN CONTROL SL

K991182 · Dade Behring, Inc. · JJY · May 19, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991182
• Device Name: MODIFICATION OF N/T PROTEIN CONTROL SL
• Applicant: Dade Behring, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with the Behring Nephelometer Systems: IgG, IgA, IgM, C3c, C4, Transferrin, Albumin, a-antitrypsin, a2-macroglobulin, Haptoglobin, a1-acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, b2-microglobulin, Soluble transferrin receptor (sTfR), Ferritin, IgE; and, by immunoturbidmetry with the TurbiTimeSystem: IgG, IgA, IgM, C3c, C4, Transferrin, Albumin, Haptoglobin, a1-acid glycoprotein. The controls can also be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.

Device Story

N/T Protein Control SL is a liquid control material derived from human serum with added stabilizers and preservatives. It serves as an assayed quality control for monitoring accuracy and precision of human serum protein assays. Used in clinical laboratories, it is processed on Behring Nephelometer Systems and TurbiTimeSystem platforms. Healthcare providers use the control results to validate the performance of diagnostic assays, ensuring reliable patient test results. The device provides a stable reference point for laboratory quality assurance.

Clinical Evidence

Bench testing only. Stability evaluated per in-house protocols; control stable for 12 months at +2° to +8° C (unopened) and 14 days at +2° to +8° C (opened).

Technological Characteristics

Liquid control material prepared from human serum; includes stabilizers and preservatives. Designed for use with immunonephelometry and immunoturbidimetry systems. Stability: 12 months unopened, 14 days opened at +2° to +8° C.

Indications for Use

Indicated for use as accuracy and precision assayed controls for human serum protein quantification via immunonephelometry or immunoturbidimetry in clinical laboratory settings.

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 SL (K964065)

Submission Summary (Full Text)

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MAY 19 1999

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

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

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

Manufacturer:

Contact Information:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Carolyn K. George Tel: [phone]

Preparation date:

April 5, 1999

#### Device Name/ Classification: 2.

N/T Protein Control SL:

Classification Number:

Class I (862.1660)

Quality Control Material (assayed)

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

N/T Protein Control SL (K964065)

#### Device Description: 4.

N/T Protein Control SL is a liquid control prepared from human serum with stabilizers and Nr 1 rotein Oontrol October of a liquia contracy and precision control for the preservative: 16 minin serum proteins by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.

#### Device Intended Use: ક.

N/T Protein Controls SLIL, M, and H are for use as accuracy and precision controls in the 14/11 Toteln Gontrolo ODE, will han serum proteins by immunonephelometry with the delehring Nephelometer Systems: IgG, IgG+++ IgA, IgM, C3c, C4, Transferrin, Albumin, a++ antitrypsin, a2-macroglobulin, Haptoglobin, a1-acid glycoprotein, Prealbumin, antil Jpoin, αշ maorogiou & kappa, βչ-microglobulin, Soluble transferrin, Soluble transferrin, Gerdloplasmin, Nor , igre onain larks and by immunoturbidmetry with the TurbiTimeSystem: IgG, roopler (GTTT), COMAN), C3c, C4, Transferrin, Albumin, Haptoglobin, x1-acid glycoprotein, The rg of in the many be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.

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

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

The N/T Protein Control SL (modified to include sTfR) is substantially equivalent in intended use to the N/T Protein Control SL (K964065) currently marketed. The N/T Control SL (modified), like the current N/T Protein Control SL is intended to be used as quality control material to monitor the accuracy and precision of human serum protein assays on the Behring Nephelometer Systems and TurbiTimeSystem.

#### 7. Device Performance Characteristics:

### Stability:

Stability was evaluated according to in-house protocols and the control was found to be stable for at least 12 months at +2° to +8° C, as originally packaged and for at least 14 days at +2° to +8° C, once opened.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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## MAY 1 9 1993

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carolyn K. Goorge Manager, Regulatory Affairs, Biology Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714

Re: K991182

Trade Name: N/T Protein Control SL: Quality Control Material Regulatory Class: 1 Product Code: JJY Dated: April 5, 1999 Received: April 7, 1999

Dear Ms. George :

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 latt 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 adultcration.

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 cquivalent 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 unight 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 procced 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 Autman

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 SL 510(k) Notification

# Indications for Use Statement

Device Name: N/T Protein Control SL

Indications for Use:

N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with the Behring Nephelometer Systems: IgG, IgGirl IgA, IgM, C3c, C4, Transferrin, Albumin, a-antitrypsin, α2-macroglobulin, Haptoglobin, a - acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, β>-microglobulin, Soluble transferrin receptor (sTfR), Ferritin, lgE; and, by immunoturbidmetry with the TurbiTimeSystem: (gG, IgGj1, IggA, controls con also be has be haptoglobin, a ;- acid glycoprotein, The controls can also be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------------------------------|
| | |
| | (Division Sign-Off) |
| | Division of Clinical Laboratory Devices |
| | 510(k) Number F791182 |
| Prescription Use<br>(Per 21 CFR 801.109) | Over-The-Counter-Use<br>(Optional Format 1-2-96) |

**CONFIDENTIAL**