IMUBIND TPA ELISA, MODEL 860

K013492 · American Diagnostica, Inc. · GGP · Mar 13, 2002 · Hematology

Device Facts

• Record ID: K013492
• Device Name: IMUBIND TPA ELISA, MODEL 860
• Applicant: American Diagnostica, Inc.
• Product Code: GGP · Hematology
• Decision Date: Mar 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Indications for Use

IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma. This kit is for in vitro diagnostic use.

Device Story

IMUBIND tPA ELISA is an enzyme-linked immunosorbent assay (ELISA) kit used for the quantitative measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma samples. The device is intended for in vitro diagnostic use in clinical laboratory settings. The assay utilizes immunological binding principles to detect tPA antigen levels. Healthcare providers use the resulting quantitative measurements to assess clinical conditions associated with elevated tPA, such as myocardial infarction, atherosclerosis, stroke, and late-stage pregnancy. The device provides diagnostic information to assist in clinical decision-making regarding these conditions.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison studies against the predicate device using 361 samples across two lots, showing positive correlation (R=0.90-0.904). Precision studies (intra-assay and inter-assay) conducted across three lots with N=20 per control sample; intra-assay CV% ranged from 3.7% to 6.0%, and inter-assay CV% ranged from 2.3% to 9.0%.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for quantitative antigen detection. In vitro diagnostic kit format. No electronic components, software, or connectivity features.

Indications for Use

Indicated for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma. Levels of tPA are known to be elevated in late stage pregnancy, myocardial infarction, atherosclerosis, and stroke.

Predicate Devices

• TintElize® tPA (K934314)

Submission Summary (Full Text)

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# MAR 1 3 2002

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IMUBIND® tPA 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: K013492

#### Submitted by:

American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830 Phone: [phone] 661-7784 Fax:

#### Contact:

Clare Santulli Field Trial Coordinator Phone: [phone]

# Summary Revised:

January 4, 2002

#### Name of the Device:

IMUBIND® tPA ELISA Product No. 860

#### Classification Name(s):

Test, Quantitative Factor Deficiency 864.7290 GGP Hematology, Class II

#### Predicate Device:

TintElize® tPA K934314

#### Intended Use:

IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma. This kit is for in vitro diagnostic use.

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### Summary of Substantial Equivalence:

IMUBIND tPA ELISA is substantially equivalent to the commercially available predicate device (TintElize tPA, manufactured by Riopool International, Ventura, CA) in performance and intended use.

#### Summary of Performance Data:

#### Method Comparison

Method Comparison studies versus the predicate device were performed with two different lots of MUBIND tPA ELISA. The regression statistics in Table 1 indicate a positive correlation, between the IMUBIND tPA ELISA assay and the predicate device.

| IMUBIND tPA<br>ELISA | N | Regression Equation | R | Sy.x<br>(ng/ml) | Sample Range<br>(ng/ml) |
|----------------------|-----|---------------------|-------|-----------------|-------------------------|
| Lot 1 | 286 | Y=0.79x--0.6 | 0.904 | 4.42 | 1.6-18.0 |
| Lot 2 | 75 | Y=0.83x+0.3 | 0.90 | 1.26 | 3.1-23.2 |

Table 1: Correlation (Y=IMUBIND. X=predicate device)

#### Precision

Precision studies evaluated intra-assay and inter-assay variability with 2 control samples run in replicates of 4 over 10 runs (N=20 per control). Assay results (ng/ml) were calculated using duplicate determinations. Three lots of IMUBIND tPA ELISA were evaluated.

#### Table 2: Precision

| IMUBIND tPA<br>ELISA | Mean<br>(ng/ml) | Intra-Assay<br>CV% | Inter-Assay<br>CV% |
|----------------------|-----------------|--------------------|--------------------|
| Lot 1 | 6.8 | 3.7 | 8.9 |
| | 15.4 | 4.1 | 9.0 |
| Lot 2 | 6.5 | 4.9 | 8.2 |
| | 14.9 | 4.2 | 4.0 |
| Lot 3 | 5.6 | 6.0 | 6.7 |
| | 14.6 | 3.8 | 2.3 |

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### Section 4

# SUBSTANTIAL EQUIVALENCE COMPARISON

A comparison table of the relevant similarities and differences between IMUBIND tPA ELISA and the predicate device:

| | IMUBIND tPA ELISA | TintElize tPA |
|-----------------------------|-------------------|---------------|
| Intended Use | Similar | Similar |
| Principle and Method | Similar | Similar |
| Reagents | Similar | Similar |
| Storage and Stability | Similar | Similar |
| Specimen | Similar | Similar |
| Limitations | Similar | Similar |
| Expected Values | Similar | Similar |
| Performance Characteristics | Similar | Similar |

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

IMUBIND tPA ELISA is substantially equivalent to the commercially available predicate device (TintElize tPA, 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 seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its head turned to the right, and three lines extending from its neck, representing the department's focus on health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John B. Berryman Director of Regulatory Affairs American Diagnostica Inc. 222 Railroad Avenue P.O. Box 1165 Greenwich, Connecticut 06836-1165

Re: k013492

> Trade/Device Name: IMUBIND® tPA ELISA Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GGP Dated: January 7, 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.

MAR 1 3 2002

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 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 Sutman

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:

Device: IMUBIND® tPA ELISA

### Indications for Use:

IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma.

This kit is for in vitro diagnostic use.

Levels of tPA in plasma are known to be elevated in late stage pregnancy, myocardial infarction, atherosclerosis, and stroke.

Angelini Battisti

(Division Sigh-Off Division of Clinical Laboratory Devices

510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)