CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS

K011658 · Rochdiag · JIX · Jul 31, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011658
• Device Name: CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
• Applicant: Rochdiag
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jul 31, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.

Device Story

C.f.a.s. Lipids is a multi-analyte calibrator consisting of liquid human serum with added biological materials to achieve specific component levels. It is used in clinical laboratories to establish calibration curves for Roche lipid methods on automated clinical chemistry analyzers. The device provides known values for constituent analytes, including Apolipoprotein A1, Apolipoprotein B, Cholesterol, HDL-cholesterol, LDL-cholesterol, Phospholipids, and Triglycerides. By calibrating the analyzer, the device ensures the accuracy of quantitative lipid measurements, which assists healthcare providers in assessing patient lipid profiles and managing cardiovascular health.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human serum matrix with added biological constituents. Single-level calibrator. Reconstitution required. Stability: 8 hours at 15-25°C, 5 days at 2-8°C, 1 month at -20°C. Designed for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the calibration of Roche lipid methods on automated clinical chemistry analyzers in a clinical laboratory setting.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• C.f.a.s. HDL/LDL-C plus (K974825)

Submission Summary (Full Text)

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K01658

## JUL 3 1 2001

#### 510(k) Summary

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter name, address, contact

Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250 [phone]

and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the con

Contact Person: Helen T. Torney

Date Prepared: May 24, 2001

Device Name

Proprietary name: Calibrator for Automated Systems (C.f.a.s.) Lipids

Common name: C.f.a.s. Lipids

Classification name: Calibrator, Multi-analyte mixture

and the comments of the comments of the comments of the comments of

Device Description The Calibrator for Automated Systems (C.f.a.s.) consists of liquid human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.

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### 510(k) Summary, Continued

| Intended use | For use in the calibration of Roche lipid methods on automated clinical<br>chemistry analyzers. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence | The Calibrator for Automated Systems (C.f.a.s.) Lipids is substantially<br>equivalent to other devices legally marketed in the United States. We claim<br>equivalence to the Roche Diagnostic Calibrator for Automated Systems<br>(C.f.a.s.) HDL/LDL-C plus (K974825). The intended use of both devices is<br>the establishment of calibration curves for their respective test systems. |

Substantial equivalence similarities

The following table compares the Calibrator for Automated Systems (C.f.a.s.) Lipids with the predicate device.

| Feature | C.f.a.s. Lipids | C.f.a.s. HDL/LDL-C plus<br>(Predicate Device) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the calibration of<br>Roche lipid methods on<br>automated clinical chemistry<br>analyzers. | For use in the calibration of<br>homogeneous Roche methods<br>for the quantitative<br>determination of HDL-<br>cholesterol and LDL-<br>cholesterol on automated<br>clinical chemistry analyzers. |
| Format | Pooled human sera with<br>constituents added as<br>required to obtain-<br>component levels. | Pooled human sera with<br>constituents added as required<br>to obtain desired component<br>levels. |
| Stability | Stability of lyophilized<br>calibrator at 2-8°C. until<br>expiration date. Stability of reconstituted<br>calibrator:<br>8 hours at 15-25°C.<br>5 days at 2-8°C.<br>1 month at -20°C. | Stability of lyophilized<br>calibrator at 2-8°C until<br>expiration date. Stability of reconstituted<br>calibrator:<br>1 day at 15-25°C.<br>5 days at 2-8°C.<br>1 month at -20°C. |
| Levels | Single Level | Single Level |
| Matrix | Lyophilized | Lyophilized |

.

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### 510(k) Summary, Continued

1. 1. 1. 1.

Substantial equivalence differences

Comparison of proposed Calibrator for Automated Systems (C.f.a.s.) Lipids and predicate device. .

| Feature | C.f.a.s. Lipids | C.f.a.s. HDL/LDL-C plus<br>(Predicate Device) |
|-------------------------|--------------------|-----------------------------------------------|
| Constituent<br>Analytes | Apolipoprotein A 1 | HDL-cholesterol |
| | Apolipoprotein B | LDL-cholesterol |
| | Cholesterol | |
| | HDL-cholesterol | |
| | LDL-cholesterol | |
| | Phospholipids | |
| | Triglycerides | |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 3 1 2001

Ms. Helen T. Torney Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457

510(k) Number: K011658 Re: JTO(K) Nambor. 110. Calibrator for Automated Systems (C.f.a.s.) Lipids Regulation Number: 862.1150 Regulatory Class: II Product Code: JIX Dated: May 24, 2001 Received: May 29, 2001

Dear Ms. Torney:

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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device microlate commored pror to tray 20, 20, 2011, 2017 11:40 pm
Amendments, or to devices that have been reclassified in accordance with the provisions of the Amendinone, of to avrieosmetic Act (Act). You may, therefore, market the device, subject to r coolar Food, Brag, and Common the Act. The general controls provisions of the Act include the general of 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 (1 remarket rippt of ally in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing i A substantially ogal rates and (GMP) regulation (21 CFR Part 820) and that, through I faction inspections, the Food and Drug Administration (FDA) will verify such penodio GMP mispections with the GMP regulation may result in regulatory action. In assumptions: T andre to oblight further announcements concerning your device in the Federal addition, I Dri may pather sesponse to your premarket notification submission does not affect reeister. Flease noter thave under sections 531 through 542 of the Act for devices under the ally obtigation you inight in Control provisions, or other Federal laws or regulations.

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Page 2

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, (Jease contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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# Indications for Use Statement

510(k) Number (if known): N/A

Device Name: Calibrator for Automated Systems (C.f.a.s.) Lipids

Indications For Use:

For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Joan Cooper
(Division ign-Off)
Division of Clinical Laboratory vices
510(k) Number KD11658