(94 days)
Not Found
No
The device description and performance studies indicate a standard immunoassay based on chemical reactions and visual interpretation of lines, with no mention of computational analysis or learning algorithms.
No.
The device is an immunoassay for the rapid qualitative detection of cardiac troponin I (cTnI) to aid in the diagnosis of myocardial infarction. It is a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the device "provides an aid in the diagnosis of myocardial infarction."
No
The device description clearly outlines physical components like a test strip, conjugate pad, and nitrocellulose membrane, indicating it is a hardware-based immunoassay test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "rapid qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum." This involves testing a sample taken from the human body (in vitro) to provide information about a physiological state (diagnosis of myocardial infarction).
- Device Description: The description details a "lateral flow chromatographic immunoassay," which is a common type of in vitro diagnostic test. It describes the components that interact with the biological sample.
- Performance Studies: The document describes studies evaluating the device's performance using "clinically confirmed serum specimens" and "samples with the concentration of human cardiac troponin I." These are tests performed on biological samples outside of the body.
- Key Metrics: The reported metrics (sensitivity, specificity, accuracy) are standard performance indicators for IVD devices.
- Predicate Device: The mention of a "Predicate Device" with a K number (K023505) indicates that this device is being compared to a previously cleared medical device, which is a common process for IVDs seeking regulatory approval.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INSTANT-VIEW Troponin I Test is an immunoassay for the rapid qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum at a cutoff level of 1.5 ng/ml. It provides an aid in the diagnosis of myocardial infarction in emergency room, point-of-care, and hospital setting.
The INSTANT-VIEW Troponin I Test provides a qualitative result rather than information about change in the level of cTnI with single testing. Serial testing should be performed to determine a temporal change in the level of cTnI. If desired, a quantitative method should be used to quantitate the concentration of cTnI. Clinical consideration and professional judgment should be applied when making a diagnosis decision based on this test result.
Product codes (comma separated list FDA assigned to the subject device)
MMI
Device Description
A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with anti- Troponin I antibodies, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with anti- Troponin I antibodies, and the C line is coated with goat anti-mouse IgG antibodies.
The proposed device has two formats: Serum Test and Whole Blood/Serum Test. The Serum Test has two sub-formats: Cassette and Dip Strip. The Whole Blood/Serum Test only has the cassette format. A cassette is a device that assembles a dip-strip in a plastic housing. The studies demonstrate all the formats are equivalent.
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
emergency room, point-of-care, and hospital setting.
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
The sensitivity and specificity of the device was evaluated against 300 clinically confirmed serum specimens, 150 positive and 150 negative.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sensitivity and Specificity Study: The sensitivity and specificity of the device was evaluated against 300 clinically confirmed serum specimens, 150 positive and 150 negative. The results demonstrated that the INSTANT-VIEW® Troponin I Test have a sensitivity of 99.3% (149/150) and a specificity of 96.0% (144/150). The overall accuracy of this device is 97.7% (293/300).
Reproducibility study: Reproducibility studies were performed on 80 samples with the concentration of human cardiac troponin I evenly distributed at four different levels: 0, 0.1, 1.5, 10 ng/ml. Each sample was tested at three physician's office laboratories (POLs) and one medical analysis laboratory. The agreements at the four sites were over 98.8%.
Interference and Cross-reactivity Study: No cross-reaction was observed with the closely related substances, such as troponins other than human cardiac troponin bilirubin, and cholesterols. No interference was observed with endogenous substances including commonly used drugs or analytes at a concentration of 10 ug/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 99.3% (149/150)
Specificity: 96.0% (144/150)
Overall accuracy: 97.7% (293/300)
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.
VBL Serum Troponin I Test by Vancouver Biotech LTD. K023505
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
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
| NOV 19 2004 | | 510(k) Summary of
Safety and Effectiveness as Required by 21 CFR 807.92 |
|------------------------------|----------------------------|------------------------------------------------------------------------------------------------|
| Manufacture and
Submitter | Name: | Alfa Scientific Designs, Inc. |
| | Address: | 12330 Stowe Drive
Poway, CA 92064
Telephone: (858) 513-3888 x 308
Fax: (858) 513-8388 |
| | Contact Person:
E-mail: | Naishu Wang, MD, Ph.D.
wnss@alfascientific.com |
| | Device Name | Trade Name: |
| | | Common Name: |
| Classification: | | |
| | Creatine phosphokinase/creatine kinase or isoenzymes
test system |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary
Preparation | August 12, 2004 |
| Predicate Device | VBL Serum Troponin I Test by Vancouver Biotech LTD.
K023505 |
| Device Description | A one-step lateral flow chromatographic immunoassay. The test
strip in the device consists of 1) a burgundy-colored conjugate pad
containing colloidal gold coupled with anti- Troponin I antibodies,
and 2) nitrocellulose membrane containing a test line (T line) and a
control line (C line). The T line is coated with anti- Troponin I
antibodies, and the C line is coated with goat anti-mouse IgG
antibodies. |
| Summary of the
Similarity to the
Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays.
• Both are qualitative tests.
• Both are in-vitro diagnostic devices.
• Both have a built-in quality control feature, C line, to indicate that
an adequate volume of sample is applied and the liquid flow
occurred properly |
1
| Intended Use | The INSTANT-VIEW Troponin I Test is an immunoassay for the rapid
qualitative detection of cardiac troponin I (cTnI) in human whole
blood or serum at a cutoff level of 1.5 ng/ml. It provides an aid in
the diagnosis of myocardial infarction in emergency room, point-of-
care, and hospital setting. |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity and
Specificity Study | The sensitivity and specificity of the device was evaluated against
300 clinically confirmed serum specimens, 150 positive and 150
negative. The results demonstrated that the INSTANT-VIEW® Troponin
I Test have a sensitivity of 99.3% (149/150) and a specificity of
96.0% (144/150). The overall accuracy of this device is 97.7%
(293/300). |
| Reproducibility
study | Reproducibility studies were performed on 80 samples with the
concentration of human cardiac troponin I evenly distributed at four
different levels: 0, 0.1, 1.5, 10 ng/ml. Each sample was tested at
three physician's office laboratories (POLs) and one medical
analysis laboratory. The agreements at the four sites were over
98.8%. |
| Interference and
Cross-reactivity
Study | No cross-reaction was observed with the closely related substances,
such as troponins other than human cardiac troponin bilirubin, and
cholesterols.
No interference was observed with endogenous substances including
commonly used drugs or analytes at a concentration of 10 ug/ml. |
| Formats of the
Device | The proposed device has two formats: Serum Test and Whole
Blood/Serum Test. The Serum Test has two sub-formats: Cassette
and Dip Strip. The Whole Blood/Serum Test only has the cassette
format. A cassette is a device that assembles a dip-strip in a plastic
housing. The studies demonstrate all the formats are equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross
reactivity, and interference studies demonstrate that the INSTANT-
VIEW Troponin I Test is substantially equivalent to the predicate
device. |
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a wing-like structure at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 9 2004
Naishu Wang, MD., Ph.D. President Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway, CA 92064
K042227 Re: Trade/Device Name: INSTANT-VIEW® Troponin I Serum Test (Cassette) INSTANT-VIEW® Troponin I Serum Test (Dip Strip) INSTANT-VIEW® Troponin I Whole Blood/Serum Test (Cassette) Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: October 28, 2004 Received: November 4, 2004
Dear Dr. Wang:
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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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Cornelius B. Loker
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K04 2227
Device Name: INSTANT-VIEW® Troponin I Serum Test (Cassette) INSTANT-VIEW® Troponin I Serum Test (Dip Strip) INSTANT-VIEW® Troponin I Whole Blood/Serum Test (Cassette)
Indications For Use:
The INSTANT-VIEW Troponin I Test is an immunoassay for the rapid qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum at a cutoff level of 1.5 ng/ml. It provides an aid in the diagnosis of myocardial infarction in emergency room, point-of-care, and hospital setting.
The INSTANT-VIEW Troponin I Test provides a qualitative result rather than information about change in the level of cTnI with single testing. Serial testing should be performed to determine a temporal change in the level of cTnI. If desired, a quantitative method should be used to quantitate the concentration of cTnI. Clinical consideration and professional judgment should be applied when making a diagnosis decision based on this test result.
Prescription Use_ ✓ (Pert 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)
Carol Beman
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042227
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