(94 days)
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.
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.
Acceptance Criteria and Study for INSTANT-VIEW Troponin I Test
This response analyzes the provided 510(k) summary for the INSTANT-VIEW Troponin I Test to extract information about its acceptance criteria and the study conducted to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | High (e.g., >95%) | 99.3% (149/150) |
| Specificity | High (e.g., >95%) | 96.0% (144/150) |
| Overall Accuracy | High (e.g., >95%) | 97.7% (293/300) |
| Reproducibility | High agreement (e.g., >95%) | Over 98.8% agreement |
| Cross-Reactivity | No cross-reaction | No cross-reaction observed with closely related substances |
| Interference | No interference | No interference observed with endogenous substances or commonly used drugs |
Note: The acceptance criteria are "implied" as they are not explicitly stated with numerical thresholds in the provided document. However, the study results demonstrate high performance that would typically be required for such a device.
2. Sample Size and Data Provenance for Test Set
- Sample Size: 300 clinically confirmed serum specimens (150 positive and 150 negative).
- Data Provenance: Retrospective, as the specimens were "clinically confirmed." The country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth of the 300 clinically confirmed serum specimens. The phrase "clinically confirmed" implies that the diagnosis (positive or negative for myocardial infarction) was established through standard clinical practice, likely involving medical professionals (e.g., cardiologists, emergency physicians) and other diagnostic tests, rather than a dedicated panel of experts for this specific study's ground truth.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The ground truth was based on "clinically confirmed" status, suggesting that the initial clinical diagnosis served as the reference standard without a separate adjudication process described for the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focused on the standalone performance of the device against clinically confirmed specimens.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, a standalone study was performed. The "Sensitivity and Specificity Study" section directly reports the device's performance (sensitivity, specificity, accuracy) when evaluating clinical specimens, indicating its performance without human interpretation influencing the measurement itself. The device is a rapid qualitative immunoassay, where the test strip provides the result.
7. Type of Ground Truth Used (Test Set)
The ground truth for the test set was based on clinical confirmation of myocardial infarction (positive or negative status) using human serum specimens. This is a form of outcomes data/expert diagnosis from clinical practice.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This type of immunoassay device is often developed and optimized iteratively through laboratory testing rather than traditional machine learning models requiring large, distinct training sets. The "Sensitivity and Specificity Study" likely refers to a validation set after the device's design was finalized.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is mentioned, the method for establishing its ground truth is not described. Device development for this type of immunoassay typically involves using known positive and negative controls and spiked samples to optimize reagent concentrations and test parameters during the R&D phase, rather than a formal "training set" with established clinical ground truth in the same way a software algorithm might.
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| NOV 19 2004 | 510(k) Summary ofSafety and Effectiveness as Required by 21 CFR 807.92 | |
|---|---|---|
| Manufacture andSubmitter | Name: | Alfa Scientific Designs, Inc. |
| Address: | 12330 Stowe DrivePoway, CA 92064Telephone: (858) 513-3888 x 308Fax: (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 isoenzymestest system | |
|---|---|
| Date of SummaryPreparation | 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 teststrip in the device consists of 1) a burgundy-colored conjugate padcontaining colloidal gold coupled with anti- Troponin I antibodies,and 2) nitrocellulose membrane containing a test line (T line) and acontrol line (C line). The T line is coated with anti- Troponin Iantibodies, and the C line is coated with goat anti-mouse IgGantibodies. |
| Summary of theSimilarity to thePredicate 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 thatan adequate volume of sample is applied and the liquid flowoccurred properly |
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| Intended Use | The INSTANT-VIEW Troponin I Test is an immunoassay for the rapidqualitative detection of cardiac troponin I (cTnI) in human wholeblood or serum at a cutoff level of 1.5 ng/ml. It provides an aid inthe diagnosis of myocardial infarction in emergency room, point-of-care, and hospital setting. |
|---|---|
| Sensitivity andSpecificity Study | The sensitivity and specificity of the device was evaluated against300 clinically confirmed serum specimens, 150 positive and 150negative. The results demonstrated that the INSTANT-VIEW® TroponinI Test have a sensitivity of 99.3% (149/150) and a specificity of96.0% (144/150). The overall accuracy of this device is 97.7%(293/300). |
| Reproducibilitystudy | Reproducibility studies were performed on 80 samples with theconcentration of human cardiac troponin I evenly distributed at fourdifferent levels: 0, 0.1, 1.5, 10 ng/ml. Each sample was tested atthree physician's office laboratories (POLs) and one medicalanalysis laboratory. The agreements at the four sites were over98.8%. |
| Interference andCross-reactivityStudy | No cross-reaction was observed with the closely related substances,such as troponins other than human cardiac troponin bilirubin, andcholesterols.No interference was observed with endogenous substances includingcommonly used drugs or analytes at a concentration of 10 ug/ml. |
| Formats of theDevice | The proposed device has two formats: Serum Test and WholeBlood/Serum Test. The Serum Test has two sub-formats: Cassetteand Dip Strip. The Whole Blood/Serum Test only has the cassetteformat. A cassette is a device that assembles a dip-strip in a plastichousing. The studies demonstrate all the formats are equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, crossreactivity, and interference studies demonstrate that the INSTANT-VIEW Troponin I Test is substantially equivalent to the predicatedevice. |
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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
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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
Page 1 of &
§ 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.