IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6

K060929 · Diagnostic Products Corporation · CDD · Apr 28, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060929
• Device Name: IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
• Applicant: Diagnostic Products Corporation
• Product Code: CDD · Clinical Chemistry
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer — for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia. The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

Device Story

IMMULITE 2500 Vitamin B12 and Folic Acid are solid-phase, two-site chemiluminescent enzyme immunoassays designed for use on the IMMULITE 2500 Automated Analyzer. The system processes patient serum, plasma, or whole blood samples to provide quantitative measurements of Vitamin B12 or Folic Acid. These assays are utilized in clinical laboratory settings by trained personnel. The analyzer automates the immunoassay process, producing results that clinicians use to aid in the diagnosis and treatment of anemias, including megaloblastic anemia and those associated with gastrointestinal malabsorption. By providing rapid, automated quantitative data, the device assists healthcare providers in identifying nutritional deficiencies and monitoring therapeutic interventions, ultimately supporting patient management for anemia-related conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance comparisons to the predicate IMMULITE 2000 systems.

Technological Characteristics

Solid-phase, two-site chemiluminescent enzyme immunoassay. Designed for use with the IMMULITE 2500 Automated Analyzer. Analyte detection via chemiluminescence. System is intended for professional in vitro diagnostic use.

Indications for Use

Indicated for use by trained laboratory professionals for the performance of immunoassays on the IMMULITE 2500 Automated Immunoassay Analyzer, including the measurement of Vitamin B12 and Folic Acid.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Predicate Devices

• IMMULITE 2500 Automated Immunoassay Analyzer (K033234)

Submission Summary (Full Text)

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K0600929

## IMMULITE 2500 Vitamin B12

113 28 276

### 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

| Name: | Diagnostic Products Corporation (DPC) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 5210 Pacific Concourse Drive<br>Los Angeles, California 90045-6900 |
| Telephone Number: | [phone] |
| Facsimile Number: | [phone] |
| Contact Person: | Deborah L. Morris<br>Director, Clinical Affairs & Regulatory Submissions |
| Date of Preparation: | April 4, 2006 |
| Device Name:<br>Trade: | IMMULITE® 2500 Vitamin B12 |
| Catalog Number: | L5KVB |
| 21 CFR 862.1810: | A vitamin B12 test system is a device intended to measure<br>vitamin B12 in serum, plasma, and urine. Measurements obtained<br>by this device are used in the diagnosis and treatment of anemias<br>of gastrointestinal malabsorption. |
| Common: | Vitamin B12 test system |
| Classification: | Class II device; Product Code: CDD (21 CFR 862.1810) |
| Panel: | Clinical Chemistry |
| CLIA Complexity Category: | We believe the category to be moderate based on previous<br>classification of analogous tests. |
| Manufacturer: | Diagnostic Products Corporation (DPC)<br>5700 West 96th Street<br>Los Angeles, California 90045-5597<br><br>Diagnostic Products Corporation (DPC)<br>5210 Pacific Concourse Drive<br>Los Angeles, California 90045-6900 |
| Establishment Registration<br>Number: | DPC's Registration Numbers are: |
| | Diagnostic Products Corporation (DPC)<br>5700 West 96th Street |
| | Los Angeles, California 90045-5597<br>Registration #: 2017183 |
| | Diagnostic Products Corporation (DPC)<br>5210 Pacific Concourse Drive |
| | Los Angeles, California 90045-6900<br>Registration #: 3005250747 |
| Substantially<br>Equivalent | |
| Predicate Device: | IMMULITE 2000 Vitamin B12 (K993251) |
| Description of Device: | IMMULITE 2500 Vitamin B12 is a solid-phase, two-site<br>chemiluminescent enzyme immunoassay for use with the<br>IMMULITE 2500 Automated Analyzer. |

## 0009 ***

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Intended Use of the Device: The IMMULITE 2500 Vitamin B12 is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.

### Conclusion:

The information presented in this Special 510(k) is that which the Food and Drug Administration used in granting Diagnostic Products Corporation substantial equivalence for IMMULITE 2500 Viramin B12.

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## IMMULITE 2500 Folic Acid 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

| Name: | Diagnostic Products Corporation (DPC) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 5210 Pacific Concourse Drive<br>Los Angeles, California 90045-6900 |
| Telephone Number: | [phone] |
| Facsimile Number: | [phone] |
| Contact Person: | Deborah L. Morris<br>Director, Clinical Affairs & Regulatory Submissions |
| Date of Preparation: | April 4, 2006 |
| Device Name:<br>Trade: | IMMULITE® 2500 Folic Acid |
| Catalog Number: | L5KFO |
| 21 CFR 862.1295: | A folic acid test system is a device intended to measure the<br>vitamin folic acid in plasma and serum. Folic acid measurements<br>are used in the diagnosis and treatment of megaloblastic anemia,<br>which is characterized by the presence of megaloblasts (an<br>abnormal red blood cell series) in the bone marrow. |
| Common: | Folic Acid test system |
| Classification: | Class II device; Product Code: CGN (21 CFR 862.1295) |
| Panel: | Clinical Chemistry |
| CLIA Complexity<br>Category: | We believe the category to be moderate based on previous<br>classification of analogous tests. |
| Manufacturer: | Diagnostic Products Corporation (DPC)<br>5700 West 96th Street<br>Los Angeles, California 90045-5597<br><br>Diagnostic Products Corporation (DPC)<br>5210 Pacific Concourse Drive<br>Los Angeles, California 90045-6900 |

## 0000160

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| Establishment Registration Number: | |
|------------------------------------|--|
|------------------------------------|--|

DPC's Registration Numbers are:

| | Diagnostic Products Corporation (DPC)<br>5700 West 96th Street<br>Los Angeles, California 90045-5597<br>Registration #: 2017183 |
|--|-------------------------------------------------------------------------------------------------------------------------------------------|
| | Diagnostic Products Corporation (DPC)<br>5210 Pacific Concourse Drive<br>Los Angeles, California 90045-6900<br>Registration #: 3005250747 |

| Substantially Equivalent Predicate Device: | IMMULITE 2000 Folic Acid (K993254) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of Device: | IMMULITE 2500 Folic Acid is a solid-phase, two-site<br>chemiluminescent enzyme immunoassay for use with the<br>IMMULITE 2500 Automated Analyzer. |

Intended Use of the Device: The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

#### Conclusion:

The information presented in this Special 510(k) is that which the Food and Drug Administration used in granting Diagnostic Products Corporation substantial equivalence for IMMULITE 2500 Folic Acid.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. 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

APR 2 8 2006

Ms. Deborah L. Morris Director of Clinical Affairs & Regulatory Submissions Diagnostic Products Corporation 5210 Pacific Concourse Drive Los Angeles CA 90045

Re: k060929

> Trade/Device Name: IMMULITE 2500 Vitamin B12 IMMULITE 2500 Folic Acid Regulation Number: 21 CFR§862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: CDD, CGN Dated: April 4, 2006 Received: April 5, 2006

Dear Ms. Morris:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Alberto G.

Alberto Gutierrez, 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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# Indications for Use

510(k) Number (if known):

IMMULITE 2500 Vitamin B12 Device Name:

Indications For Use:

The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer — for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Division

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## Indications for Use

K060929 510(k) Number (if known):

IMMULITE 2500 Folic Acid Device Name:

Indications For Use:

The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

C.J.C.
Division Sign-Off

Office of In Vitm Diagnostic Device Evaluation and Safety

1083 K060929

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