ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10

K011853 · Bio-Rad · JJY · Jul 17, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011853
• Device Name: ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 17, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Abbott Tumor Marker - MCC (Lyophilized) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.

Device Story

Abbott Tumor Marker - MCC (Lyophilized) is a human serum-based quality control product; contains added constituents of human origin and pure chemicals. Provided in lyophilized form for stability. Used in clinical laboratories to monitor precision of testing procedures for tumor marker analytes. Healthcare providers use the control to verify assay performance; results help ensure accuracy of patient diagnostic testing. Device is intended for professional use in laboratory environments.

Clinical Evidence

Bench testing only. Stability studies confirmed: 14-day open-vial stability at 2-8°C (except Free PSA/PSA); 30-day stability after reconstitution and freezing at -10°C to -20°C; 3-year and 3-month shelf life at 2-8°C.

Technological Characteristics

Human serum-based control; lyophilized form. Analyte composition includes tumor markers, B2 Microglobulin, and PAP. Storage requirements: 2-8°C unopened; -10°C to -20°C for reconstituted frozen state. No software or electronic components.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific tumor marker analytes 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

• Abbott Tumor Marker - MCC (Lyophilized) (K990610)

Submission Summary (Full Text)

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Bio-Rad Laboratories Premarket Notification Section 510(k) for Abbott Turnor Marker -- MCC (Lyophilized) Summary of Safety and Effectiveness

711853

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# Summary of Safety and Effectiveness Abbott Tumor Marker - MCC (Lyophilized)

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: [phone] Fax: [phone]

## Contact Person

Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

June 06, 2001

#### 2.0 Device Identification

Product Trade Name: Abbott Tumor Marker - MCC (Lyophilized)

Common Name: Multi-Analyte Controls, (Assayed and unassayed)

Classifications: Class I Product Code: 75JJY Regulation Number: CFR 862.1660

#### 3.0 Device to Which Substantial Equivalence is Claimed

Abbott Tumor Marker - MCC (Lyophilized) Bio-Rad Laboratories Irvine, California

Docket Number: K990610

#### 4.0 Description of Device

Abbott Tumor Marker - MCC (Lyophilized) is prepared from human serum with added constituents of human origin and pure chemicals.

The control is provided in lyophilized form for increased stability

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#### 5.0 Statement of Intended Use

Abbott Tumor Marker - MCC (Lyophilized) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.

#### 6.0 Comparison of the new device with the Predicate Device

The new Abbott Tumor Marker – MCC (Lyophilized) claims substantial equivalence to the Abbott Tumor Marker -- MCC (Lyophilized) currently in commercial distribution (K990610). The new Abbott Tumor Marker - MCC (Lyophilized) contains all the analytes as the predicate device plus B2 Microglobulin and PAP. The new device has improved reconstituted freeze-thaw stability claims for PSA.

| | Abbott | Abbott |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Tumor Marker - MCC (Lyophilized)<br>(New Device) | Tumor Marker - MCC (Lyophilized)<br>(Predicate Device) |
| Similarities | | |
| Intended Use | Tumor Marker - MCC<br>(Lyophilized) is intended for use<br>as a quality control serum to<br>monitor the precision of laboratory<br>testing procedures for the<br>analytes listed in the package<br>insert. | Tumor Marker - MCC<br>(Lyophilized) is intended for use as<br>a quality control serum to monitor<br>the precision of laboratory testing<br>procedures for the analytes listed<br>in the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human serum based | Human serum based |
| Open<br>Vial Claim | All analytes will be stable for 14<br>days when stored at 2 – 8°C<br>tightly capped with the following<br>exceptions: Free PSA and PSA<br>should be assayed immediately<br>following reconstitution. | All analytes will be stable for 14<br>days when stored at 2 - 8°C tightly<br>capped with the following<br>exceptions: Free PSA and PSA<br>should be assayed immediately<br>following reconstitution. |
| Storage<br>(Unopened) | 2°C to 8°C<br>until expiration date | 2°C to 8°C<br>until expiration date |

Table 1. Similarities and Differences between new and predicate device.

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| Differences | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytes<br>Claimed | All the same analytes as the<br>current Abbott Tumor Marker -<br>MCC (Lyophilized), plus B2<br>Microglobulin and PAP. | AFP, CA 15-3, CA 19-9, CA 125,<br>CEA, Free PSA, PSA. |
| Reconstituted<br>Freeze Vial<br>Claim | All analytes will be stable after<br>reconstituting and freezing for 30<br>days when stored at -10°C to -<br>20°C. | All analytes will be stable for 30<br>days after reconstituting and<br>freezing when stored at -10°C to -<br>20°C, with the following<br>exceptions: (1) PSA will be stable<br>for 20 days. |

Table 1. Similarities and Differences between new and predicate device, continued.

#### 7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Abbott Tumor Marker - MCC (Lyophilized). Product claims are as follows:

- Once the control is reconstituted, all analytes will be stable for 14 days 7.1 when stored tightly capped at 2 - 8℃, with the following exceptions: Free PSA and PSA should be assayed immediately following reconstitution.
- After reconstituting and freezing the control, all analytes will be stable for 7.2 30 days when stored tightly capped at -10℃ to -20℃. Once thawed, do not refreeze the control; discard remaining material.
- The control is stable for 3 years and 3 months when stored unopened at 2 7.3 - 8℃.

Real time studies will be ongoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 7 2001

Ms. Donna Chapman Quality Assurance/Regulatory Affairs Manager Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017

510(K) Number: K011853 Re: 510(11) Frade/Device Name: Abbott Tumor Marker - MCC (Lyophilized) Regulation Number: 862.1160 Regulatory Class: I Product Code: JJY Dated: June 6, 2001 Received: June 13, 2001

Dear Ms. Chapman:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becally in the substantially equivalent (for the indications for use above and we nave determined the actives marketed predicate devices marketed in interstate commerce stated in the encrosure) to legally manetes of the Medical Device Amendments, or to devices that provity 20, 1970, are encounces with the provisions of the Federal Food, Drug, and Tiave been tectassified in accordance market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general controliberturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see associates and additional controls. Existing major regulations (Fremarks Approvary, it the Code of Federal Regulations, Title 21, Parts 800 to 895. affecting your do rios can determination assumes compliance with the Current Good A substantany equirements, as set forth in the Quality System Regulation (QS) for Manufacturing Fraction regulation (21 CFR Part 820) and that, through periodic QS Medical Devices. General regulation (FDA) will verify such assumptions. Failure to inspections, the Food and Drug result in regulatory action. In addition, FDA may publish comply with the GMT regaration in our device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might It spollse to your promations of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and in you to objak antial equivalence of your device to a legally marketed noutication. The I Drice results in 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 If you desire specific active for your atic devices), please contact the Office of Compliance at additionally 007.10 for mirring and stimment on the promotion and advertising of your device, [phone]: Traditionally, 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 mormation on your rooperation.oll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrl/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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510 (k) Number (if known):_ 竹O川8S3

Abbott Tumor Marker - MCC (Lyophilized) Device Name:

Indications for Use:

Abbott Tumor Marker – MCC (Lyophilized) is intended for use as an assayed Abbott Tamor Mariotr the precision of laboratory testing procedures for the analytes listed in the insert.

Jacket

(Division/Sign-Off) Division Laboratory Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use or

Over-the Counter use