LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS

K102700 · Alere, San Diego, Dba Biosite INcorporated, Dba IN · JJY · Dec 21, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102700
• Device Name: LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
• Applicant: Alere, San Diego, Dba Biosite INcorporated, Dba IN
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Lipid Controls: Intended Use: Assayed quality control materials for use with the Alere Cholestech LDX® system. Indications for Use: Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System. Multianalyte Control: Intended Use: Assayed quality control materials for use with the Alere Cholestech LDX® system. Indications for Use: Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System. Calibration Verification: Intended Use: Assayed calibration verification material is designed to be used for verifying the reportable range of tests on the Alere Cholestech LDX® System. Indications for Use: This material is designed for use with any Alere Cholestech LDX® cassette type that includes total cholesterol, HDL cholesterol, triglycerides and glucose.

Device Story

Assayed quality control and calibration verification materials for Alere Cholestech LDX® system; used by clinical laboratory personnel to monitor test procedure performance and verify reportable ranges for lipid and glucose assays. Device serves as a reference standard to ensure system accuracy. Manufacturing site transferred from Streck to Alere San Diego; all raw materials, specifications, and manufacturing processes remain identical to predicate. No clinical data required; bench performance testing confirms substantial equivalence.

Clinical Evidence

Bench testing only. No clinical data presented. Performance testing compared the Alere-manufactured controls against the Streck-manufactured predicate, demonstrating substantial equivalence in analytical performance.

Technological Characteristics

Assayed quality control and calibration verification materials. Chemical composition and manufacturing processes are identical to the predicate device. Standalone materials used with the Alere Cholestech LDX® system.

Indications for Use

Indicated for monitoring performance of test procedures and verifying reportable range of total cholesterol, HDL cholesterol, triglycerides, and glucose tests on the Alere Cholestech LDX® System.

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

• CHEM-CHEX (K913687)

Submission Summary (Full Text)

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## 5. 510(k) Summary

D:EC 2 1 2010

12102700 510(k) number: __

Date Prepared: 17 September 2010

| Submitter: | Alere San Diego, Inc. | Contact: | Edward Brehm |
|------------|-------------------------|------------|----------------------------|
| Address: | 9975 Summers Ridge Road | | Regulatory Affairs Manager |
| | San Diego, CA 92121 | Telephone: | 858 805 3071 |
| Telephone: | 858 805 3071 | Fax: | 858 695 7100 |
| Fax: | 858 695 7100 | Email: | [e-mail] |
| | | | |

| Trade name: | Common Name (Device Type): |
|------------------------------------------------|-----------------------------------|
| Alere Cholestech LDX® Lipid Controls | Assayed Quality Control materials |
| Alere Cholestech LDX® Multianalyte Controls | |
| Alere Cholestech LDX® Calibration Verification | |

| Class: | 1 |
|--------------------|--------------------|
| Regulation number: | 21 CFR 862.1660 |
| Product Code: | JJY |
| Panel: | Clinical Chemistry |

Predicate devices: K913687 CHEM-CHEX (Streck Laboratories, Inc.)

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- 5.1. Intended Use / Indications for Use:
Lipid Controls:

Intended Use: Assayed quality control materials for use with the Alere Cholestech LDX® system.

Indications for Use: Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System.

Multianalyte Control:

Intended Use: Assayed quality control materials for use with the Alere Cholestech LDX® system.

Indications for Use: Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System.

## Calibration Verification:

Intended Use: Assayed calibration verification material is designed to be used for verifying the reportable range of tests on the Alere Cholestech LDX® System. Indications for Use: This material is designed for use with any Alere Cholestech LDX® cassette type that includes total cholesterol, HDL cholesterol, triglycerides and glucose.

5.2. Summary of Changes from Predicate Device:

The predicate devices are the Lipid Controls, Multianalyte Controls and Calibration Verification Materials manufactured by Streck for Alere. Streck will no longer be the OEM manufacturer for Alere San Diego. Streck has transferred the responsibility for manufacturing the controls from the Streck manufacturing site (Omaha, Nebraska) to the Alere manufacturing site (San Diego, California). All raw materials, vendors, raw material specifications, generic manufacturing processes, in-process test methods, final release test methods, release specifications and methods of value assignment are unchanged.

- 5.3. Substantial Equivalence to Predicate Device:
The predicate devices are the Lipid Controls, Multianalyte Controls and Calibration Verification Materials manufactured by Streck. The Lipid Controls, Multianalyte Controls and Calibration Verification Materials manufactured by Alere San Diego are substantially equivalent to the Multianalyte Controls manufactured by Streck in intended use, technology and performance. Bench performance testing was performed comparing the new device and the predicate device, and was found to be substantially equivalent.

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- ર 4. List of Similarities: Intended use is unchanged Indications for use is unchanged The operating principle is unchanged The technology is unchanged The analytical performance is unchanged or improved The manufacturing process is unchanged The formulation is unchanged
- 5.5. List of Differences: None
- 5.6. Conclusion:

Performance testing demonstrates that the Lipid Controls, Multianalyte Controls and Calibration Verification Materials manufactured by Alere San Diego are as safe, as effective and performs as well as the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

DEC 2 1 2010

Alere San Diego Inc. c/o Mr. Edward C. Brehm Regulatory Affairs Specialist 9975 Summers Ridge Road San Diego. CA 92121

Re: k102700

> Trade Name: The Alere Cholestech LDX Lipid Controls, The Alere Cholestech LDX Multianalyte Controls, The Alere Cholestech LDX Calibration Verification Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJY Dated: November 18, 2010 Received: November 19, 2010

Dear Mr. Brehm:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

•

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to previor of notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli-free nmber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## 4. Indications for Use Statement

DEC 2 1 2010

510(k) Number (if known): Device Name: Multianalyte Controls, and Alere Cholestech LDX® Calibration Verification

Indications for Use:

Lipid Controls: Alere Cholestech LDX® Lipid Controls, Level 1 and Level 2, are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System.

Multianalyte Controls: Alere Cholestech LDX® Multianalyte Controls, Level 1 and Level 2, are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System.

Calibration Verification Materials: Alere Cholestech LDX® Calibration Verification, Levels 1 -- 4, are designed to be used for verifying the reportable range of tests on the Alere Cholestech LDX® System. This material is intended for use with any Alere Cholestech LDX® cassette type that includes total cholesterol, HDL cholesterol, triglycerides and glucose.

Over-The-Counter Use n/a Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Aris

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 12/02700