IMUBIND PLASMA PAI-1 ELISA,MODEL 822

K013168 · American Diagnostica, Inc. · GGP · Mar 7, 2002 · Hematology

Device Facts

• Record ID: K013168
• Device Name: IMUBIND PLASMA PAI-1 ELISA,MODEL 822
• Applicant: American Diagnostica, Inc.
• Product Code: GGP · Hematology
• Decision Date: Mar 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Indications for Use

The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of human Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in plasma. This kit is for in vitro diagnostic use.

Device Story

IMUBIND Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay (ELISA) for quantifying PAI-1 antigen in human plasma. The device utilizes plate wells coated with anti-PAI-1 antibody to capture PAI-1 from patient samples. Following incubation and washing, bound antigen is detected via standard ELISA reagents. The assay is performed in a clinical laboratory setting by trained personnel. Results are obtained via absorbance measurements, which are used by clinicians to assess PAI-1 levels; elevated levels are clinically associated with deep vein thrombosis and myocardial infarction, aiding in the evaluation of thrombotic risk.

Clinical Evidence

Bench testing only. Method comparison studies against the predicate device demonstrated a positive correlation. Precision studies evaluated intra-assay and inter-assay variability across two lots, with intra-assay CVs ranging from 4.1% to 5.7% and inter-assay CVs ranging from 2.1% to 5.1%.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) format. Uses antibody-coated microtiter plates for antigen capture. Quantitative measurement based on absorbance. In vitro diagnostic reagent kit.

Indications for Use

Indicated for the measurement of human PAI-1 antigen in plasma for patients where high levels are associated with deep vein thrombosis and myocardial infarction.

Predicate Devices

• BIOPOOL TintElize® PAI-1 (K960438)

Submission Summary (Full Text)

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#### Section 3

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IMUBIND® Plasma PAI-1 ELISA Quantitative Factor Deficiency Test (per 21CFR864.7290)

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

The assigned 510(k) number is:

## Submitted by:

American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830 Phone: [phone] Fax: [phone]

## Contact:

Clare Santulli Field Trial Coordinator Phone: [phone]

# Summary Prepared:

August 12, 2001

#### Name of the Device:

IMUBIND® Plasma PAI-1 ELISA Product No. 822

#### Classification Name(s):

864.7290 Test, Quantitative Factor Deficiency GGP Hematology, Class II

#### Predicate Device:

BIOPOOL TintElize® PAI-1 K960438

#### Intended Use:

The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma.

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## Summary of Substantial Equivalence:

IMUBIND Plasma PAI-1 ELISA is substantially equivalent to the commercially available predicate device (TintElize PAI-1, manufactured by Biopool International, Ventura, CA) in performance and intended use.

## Summary of Performance Data:

## Method Comparison

Method comparison studies versus the predicate device were performed with one lot of IMUBIND Plasma PAI-1 ELISA. The regression statistics in Table 1 indicate a positive correlation between the IMUBIND assay and the predicate device.

| | Table 1: Correlation (Y=IMUBIND, X=predicate device) | | |
|---------|------------------------------------------------------|--------|-----|
| IMUBIND | Regression | Carlos | Sam |

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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | quation<br>Separation of Children of Children of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | And 100 Million<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 44.4<br>Acres of the |
| MILEAR READ RANGER OF C<br>Station of the trial and the collect of the closed and the charges and the commission and the comments withing the contribution and the contribution and the contribution and<br>. BIR MILE LINE LIER RESER FREELER ANNUAL | <br>----------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------- | month of the charge than the collection of the commission of the commission of the commission of the commission of the commended to the<br>MALE OF LEASE OF CHE OF CHEARTH | | B ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-------------- |

#### Precision

Precision studies evaluated intra-assay and inter-assay variability with 2 control samples run in replicates of 4 over 10 runs (N=40 per control). Two lots were evaluated.

#### Table 2: Precision

| IMUBIND<br>Plasma PAI-1 | Mean<br>(ng/ml) | Intra-Assay<br>CV% | Inter-Assay<br>CV% |
|-------------------------|-----------------|--------------------|--------------------|
| Lot 1 | 11.5 | 5.7 | 5.1 |
| | 40.9 | 4.1 | 2.1 |
| Lot 2 | 11.3 | 5.7 | 4.7 |
| | 40.3 | 4.2 | 4.7 |

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## Section 4

# SUBSTANTIAL EQUIVALENCE COMPARISON

A comparison table of the relevant similarities and differences between IMUBIND Plasma PAI-1 ELISA and the predicate device:

| | IMUBIND Plasma<br>PAI-1 ELISA | TintElize PAI-1 |
|--------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Similar | Similar |
| Principle and<br>Method | All plate wells contain<br>antibody to PAI-1 | Half of the plate wells contain antibody (A-well) to<br>PAI-1, half of the plate wells contain no antibody<br>(N-well) providing a blank to be subtracted from<br>the absorbance value for each sample |
| Reagents | Similar | Similar |
| Storage and<br>Stability | Similar | Similar |
| Specimen | Similar | Similar |
| Limitations | Similar | Similar |
| Expected Values | Similar | Similar |
| Performance<br>Characteristics | Similar | Similar |

Similar performance and values were obtained with both devices suggesting that the method difference does not affect device equivalence.

IMUBIND Plasma PAI-1 ELISA is substantially equivalent to the commercially available predicate device (TintElize PAI-1, manufactured by Biopool International, Ventura, CA) in method, performance and intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

7 2002 MAR

Mr. John Berryman Director of Regulatory Affairs American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830

Re: k013168

Trade/Device Name: IMUBIND® Plasma PAI-1 ELISA Regulation Number: 21 CFR 864.7290 Regulation Name: Factor deficiency test Regulatory Class: Class II Product Code: GGP Dated: January 8, 2002 Received: January 10, 2002

Dear Mr. Berryman:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/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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Section 2

# STATEMENT OF INDICATIONS FOR USE

Applicant:

510(k) Number: _K013168

Device:

## Indications for Use:

::

The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of human Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in plasma.

This kit is for in vitro diagnostic use.

High levels of PAI-1 antigen are known to be associated with deep vein thrombosis and myocardial infarction.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joachim Sauterki

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K013168