(142 days)
Not Found
No
The summary describes a standard ELISA assay, which is a biochemical test, and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic (IVD) assay for measuring tPA antigen in plasma, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This kit is for in vitro diagnostic use."
No
The device is an enzyme-linked immunosorbent assay (ELISA) kit, which is a laboratory test involving physical reagents and procedures, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This kit is for in vitro diagnostic use."
N/A
Intended Use / 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.
Product codes
GGP
Device Description
IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Lot 1: N=286, Regression Equation Y=0.79x--0.6, R=0.904, Sy.x (ng/ml)=4.42, Sample Range (ng/ml) 1.6-18.0
Lot 2: N=75, Regression Equation Y=0.83x+0.3, R=0.90, Sy.x (ng/ml)=1.26, Sample Range (ng/ml) 3.1-23.2
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.
Lot 1: Mean (ng/ml) 6.8, Intra-Assay CV% 3.7, Inter-Assay CV% 8.9; Mean (ng/ml) 15.4, Intra-Assay CV% 4.1, Inter-Assay CV% 9.0
Lot 2: Mean (ng/ml) 6.5, Intra-Assay CV% 4.9, Inter-Assay CV% 8.2; Mean (ng/ml) 14.9, Intra-Assay CV% 4.2, Inter-Assay CV% 4.0
Lot 3: Mean (ng/ml) 5.6, Intra-Assay CV% 6.0, Inter-Assay CV% 6.7; Mean (ng/ml) 14.6, Intra-Assay CV% 3.8, Inter-Assay CV% 2.3
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
0
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: 203 661-0000 203 661-7784 Fax:
Contact:
Clare Santulli Field Trial Coordinator Phone: 203 661-0000
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
ELISA | N | Regression Equation | R | Sy.x
(ng/ml) | Sample Range
(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
ELISA | Mean
(ng/ml) | Intra-Assay
CV% | Inter-Assay
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)