APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH

K993310 · Dade Behring, Inc. · JJY · Nov 30, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993310
• Device Name: APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
• Applicant: Dade Behring, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Apolipoprotein Control Serum CHD is used as an assayed control for accuracy and precision in the quantitative immunochemical determination of apolipoprotein A-I and B by radial immunodiffusion, apolipoprotein A-I, All*, B, E* and CRP with the Behring Nephelometer Systems, or apolipoprotein A-1, B and Myoglobin with the TurbiTime System™ *Reagents for these determinations are not available in the USA.

Device Story

Apolipoprotein Control Serum CHD is a lyophilized, human serum-based quality control material containing stabilizers and preservatives. It serves as an assayed reference to monitor the accuracy and precision of quantitative immunochemical assays. The device is used in clinical laboratory environments by laboratory personnel. It is processed alongside patient samples using radial immunodiffusion, Behring Nephelometer Systems, or the TurbiTime System™. Healthcare providers use the control results to validate the performance of the analytical systems before reporting patient test results, ensuring the reliability of apolipoprotein and myoglobin measurements.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized reagent derived from human serum; includes stabilizers and preservatives. Calibrated against in-house and commercial protein reference preparations. 0.5 ml per vial. Used for immunochemical determination via radial immunodiffusion, nephelometry, or turbidimetry.

Indications for Use

Indicated for use as an assayed quality control material to monitor accuracy and precision of human serum protein assays (Apolipoprotein A-I, AII, B, E, CRP, and myoglobin) 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

• Apolipoprotein Control Serum (K903687)

Submission Summary (Full Text)

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## 510(k) Summary For Apolipoprotein Control Serum CHD

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Donna A. Wolf<br>Dade Behring Inc.<br>P. O. Box 6101<br>Newark, Delaware 19714<br>Tel: [phone] |
|-------------------------------|-----------------------------------------------------------------------------------------------------|
| Preparation Date: | September 30, 1999 |
| Device Name / Classification: | Apolipoprotein Control Serum CHD<br>Quality Control Material (assayed) |
| Predicate Device: | Apolipoprotein Control Serum (K903687) |

Device Description: Apolipoprotein Control Serum CHD is a lyophilized reagent prepared from human serum with stabilizers and preservative. The product is calibrated against different protein standard preparations including in-house and commercially available reference preparations.

Device Intended Use: Apolipoprotein Control Serum CHD is used as an assayed control for accuracy and precision in the quantitative immunochemical determination of apolipoprotein A-I and B by radial immunodiffusion, apolipoprotein A-I, All*, B, E* and CRP with the Behring Nephelometer Systems, or apolipoprotein A-1, B and Myoglobin with the TurbiTime System™

*Reagents for these determinations are not available in the USA.

### Comparison to Predicate Device:

| | Apolipoprotein Control<br>Serum CHD (modified) | Apolipoprotein Control<br>Serum (K903687) |
|--------------|-----------------------------------------------------|-------------------------------------------------|
| Intended Use | Assayed control | Assayed control |
| Analytes | Apolipoprotein A-1, AII, B, E,<br>myoglobin and CRP | Apolipoprotein A-1, AII, B, E,<br>and myoglobin |
| Matrix | Stabilized reagent from<br>human serum | Stabilized reagent from<br>human serum |
| Form | Lyophilized | Lyophilized |
| Volume | 0.5 ml per vial | 0.5 ml per vial |

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Dade Behring Inc. Apolipoprotein Control 510(k) Notification

Comments on Substantial Equivalence: Both the Apolipoprotein Control Serum CHD and the Apolipoprotein Control are similar products. Both products are intended for use as a quality control material to monitor accuracy and precision of human serum protein assays using radial immunodiffusion, the Behring Nephelometer Systems, and the TurbiTime System™.

Conclusion: The Apolipoprotein Control Serum CHD is substantially equivalent to the Apolipoprotein Control Serum based on the comparison summarized above.

Donna A. Wolf

Regulatory Affairs and Compliance Specialist Date: September 30, 1999

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes resembling human figures or birds in flight. The logo is presented in black and white.

NOV 30 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Donna A. Wolf Regulatory Affairs Specialist. Biology Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714

Re: K993310 Trade Name: Apolipoprotein Control Serum CHD Regulatory Class: I Product Code: JJY Dated: September 30, 1999 Received: October 4, 1999

Dear Ms. Wolf:

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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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. Apolipoprotein Control 510(k) Notification

Nov 30 1999

# K993310

## Indications for Use Statement

Device Name:

Apolipoprotein Control Serum CHD

### Indications for Use:

Apolipoprotein Control Serum CHD is used as an assayed control for accuracy and precision in the quantitative immunochemical determination of

Apolipoprotein A-I and B by radial immunodiffusion;

Apolipoprotein A-I, All*, B, E* and CRP with the Behring Nephelometer Systems;

and Apolipoprotein A-I, B and Myoglobin with the TurbiTime System™

* Reagents for these determinations are not available in USA

Peter E. Madoni

(Division Sign-Off)
Division of Clinical Laboratory Devices K993310
510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use > (Per 21CFR801.109)

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

000000

CONFIDENTIAL