(285 days)
No Reference Device (s) K/DEN number specified.
No
The device description details a colorimetric assay based on enzymatic reactions, and there are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an in vitro diagnostic (IVD) kit intended for quantitative determination of PAI-1 activity in human plasma, which is used for diagnostic purposes and not for treating or preventing a disease or condition.
Yes
The device explicitly states its intended use is "for in vitro diagnostic use" for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity.
No
The device description clearly outlines a "two stage colorimetric assay" involving chemical reactions and the use of reagents (tPA, plasminogen, plasmin chromogenic substrate). This indicates a physical in vitro diagnostic kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The test is for in vitro diagnostic use".
N/A
Intended Use / Indications for Use
Spectrolyse ® PAI-1, Product # 101201, is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use and is not intended for internal use in humans and animals.
Product codes (comma separated list FDA assigned to the subject device)
GGP
Device Description
Spectrolyse @ PAI-1 is a two stage colorimetric assay. The first stage involves incubating samples with a known amount of tPA, allowing PAI-1 in the sample to react with tPA. In the second stage, the residual tPA activity converts plasminogen to plasmin, which in turn hydrolyzes a plasmin chromogenic substrate, SPECTROZYME® PL. PAI-1 in the plasma is determined as the difference between the amount of tPA added and the amount of tPA recovered.
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two method comparison studies versus the predicate device were performed with two lots of Spectrolyse® PAI-1. The regression statistics in Table 1 indicate a positive correlation between the Spectrolyse® PAI-1 assay and the predicate device.
Study 1: N=34, Regression Equation Y=1.0787X+-4.76, R=0.953, Sy.x (ng/ml)=3.31, Sample Range (ng/ml)=5.3-37.8
Study 2: N=34, Regression Equation Y=1.0179X+-3.75, R=0.955, Sy.x (ng/ml)=2.65, Sample Range (ng/ml)=5.0-42.3
Precision studies evaluated intra-assay and inter-assay variability with 3 control samples.
Study #1: control samples were run in replicates of 4 over 20 runs (N=40 per control).
Control 1: Mean (IU/mL)=10.4, Intra-Assay CV%=3.6, Inter-Assay CV%=12.9
Control 2: Mean (IU/mL)=13.8, Intra-Assay CV%=3.4, Inter-Assay CV%=7.5
Control 3: Mean (IU/mL)=22.2, Intra-Assay CV%=2.4, Inter-Assay CV%=3.9
Study #2: control samples were run in replicates of 4 over 5 runs (N=10 per control).
Control 1: Mean (IU/mL)=6.7, Intra-Assay CV%=14.4, Inter-Assay CV%=10.2
Control 2: Mean (IU/mL)=14.4, Intra-Assay CV%=3.5, Inter-Assay CV%=5.7
Control 3: Mean (IU/mL)=26.0, Intra-Assay CV%=2.0, Inter-Assay CV%=4.1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/0 description: The image shows the logo for American Diagnostica Inc. The logo consists of the letters 'ai' with a square and a drop above them, followed by seven horizontal lines. To the right of this is the text 'american diagnostica inc.' in a simple, outlined font.
Revised Section 3 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Spectrolyse 9 PAI-1 Quantitative Factor Deficiency Test (per 21CFR864.7290)
Act 1 5 2007
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: K063323
Submitted by:
American Diagnostica Inc. 500 West Avenue Stamford, CT 06902 Tel. 203 602-7777 Fax 203 602-2221
Contact:
Jodi Radassao Clare Santulli Field Trial Personnel Phone: 203 602-7777 x25
Summary Prepared:
July 27, 2007
Name of the Device:
Spectrolyse ® PAI-1 Product No. 101201
Classification Name(s):
864.7290 Test, Qualitative And Quantitative Factor Deficiency GGP Hematology Reagents, Class II
Predicate Device:
Spectrolyse/pL PAI K922782
Description of the Device
Spectrolyse @ PAI-1 is a two stage colorimetric assay. The first stage involves incubating samples with a known amount of tPA, allowing PAI-1 in the sample to react with tPA. In the second stage, the residual tPA activity converts plasminogen to plasmin, which in turn hydrolyzes a plasmin chromogenic substrate, SPECTROZYME® PL. PAI-1 in the plasma is determined as the difference between the amount of tPA added and the amount of tPA recovered.
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Intended Use:
Spectrolyse ® PAI-1, Product # 101201, is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use and is not intended for internal use in humans and animals.
Summary of Substantial Equivalence:
Spectrolyse ® PAI, Product # 101201 is substantially equivalent to the commercially available predicate device Spectrolyse® /pL PAI manufactured by BIOPOOL in performance and intended use.
Summary of Performance Data:
Method Comparison
Two method comparison studies versus the predicate device were performed with two lots of Spectrolyse® PAI-1. The regression statistics in Table 1 indicate a positive correlation between the Spectrolyse® PAI-1 assay and the predicate device.
| | N | Regression
Equation | R | Sy.x
(ng/ml) | Sample Range
(ng/ml) |
|---------|----|------------------------|-------|-----------------|-------------------------|
| Study 1 | 34 | Y=1.0787X+-4.76 | 0.953 | 3.31 | 5.3-37.8 |
| Study 2 | 34 | Y=1.0179X+-3.75 | 0.955 | 2.65 | 5.0-42.3 |
Table 1: Correlation (Y=subject device. X=predicate device)
Precision
Precision studies evaluated intra-assay and inter-assay variability with 3 control samples. In Study #1 control samples were run in replicates of 4 over 20 runs (N=40 per control). In Study #2 control samples were run in replicates of 4 over 5 runs (N= 10 per control). Assay results (IU/mL) were calculated using duplicate determinations. Two lots were evaluated.
| Table 2: Precision | |
|---|---|
| | Mean
(IU/mL) | Intra-Assay
CV% | Inter-Assay
CV% |
|-----------|-----------------|--------------------|--------------------|
| Control 1 | 10.4 | 3.6 | 12.9 |
| Control 2 | 13.8 | 3.4 | 7.5 |
| Control 3 | 22.2 | 2.4 | 3.9 |
Table 3: Precision
| | Mean
(IU/mL) | Intra-Assay
CV% | Inter-Assay
CV% |
|-----------|-----------------|--------------------|--------------------|
| Control 1 | 6.7 | 14.4 | 10.2 |
| Control 2 | 14.4 | 3.5 | 5.7 |
| Control 3 | 26.0 | 2.0 | 4.1 |
American Diagnostica, Inc.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 5 2007
American Diagnostica, Inc. C/O David Teicher 500 West Avenue Stamford, Connecticut 06902
Re: K063323
Trade/Device Name: Spectrolyse® PAI-1, Model 101201 Regulation Number: 21 CFR 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: Class II Product Code: GGP Dated: July 27, 2007 Received: July 30, 2007
Dear Mr. Teiher:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf have to hove 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 Section 510(k) I ins letter witi anow you to begin mailoning of substantial equivalence of your device to a legally prematicate 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), please rr you deen's specific an readiological Health's (CDRH's) Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to (240) 270 0461. And (21CFR Part 807.97). For questions regarding postmarket surveillance, promance notification - (216-11-15) Surveillance and Biometric's (OSB's) Division of Postmarket product CD111 - For questions regarding the reporting of device adverse events Surveinance at 240 210 3171. For questions of Surveillance Systems at 240-(Medical Dovio Reporting (112 17)) Properal information on your responsibilities under the Act from 270 -401. I ou may of the may of the mational and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Becker
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Section 2
STATEMENT OF INDICATIONS FOR USE
Applicant:
510(k) Number: _ KOCO333333
Device:_______________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Spectrolyse ® PAI-1 kit, Product # 101201, is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use and is not intended for internal use in humans and animals.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
500(k) K063323