(318 days)
Not Found
No
The device description and performance studies indicate a traditional immunoassay with visual interpretation, and there is no mention of AI or ML in the provided text.
No.
The device is described as a rapid immunoassay used as an "aid in the diagnosis of Acute Myocardial Infarction (AMI)," which is a diagnostic purpose, not a therapeutic one.
Yes
The intended use explicitly states that the device is "as an aid in the diagnosis of Acute Myocardial Infarction (AMI)".
No
The device description clearly outlines a physical, single-use, visually read cassette device containing a membrane strip and other physical components for a lateral flow immunoassay. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of Cardiac Troponin I (cTnl), Creatine Kinase MB (CK-MB), and Myoglobin in human serum and plasma specimens." This involves testing biological samples in vitro (outside the body).
- Aid in Diagnosis: The device is intended "as an aid in the diagnosis of Acute Myocardial Infarction (AMI)." This is a common purpose for IVD devices.
- Device Description: The description details a "lateral flow immunochromatography assay" that analyzes components within a biological sample (serum and plasma). This is a typical format for IVD tests.
- Professional Use: The intended user is a "Professional use," which aligns with the use of diagnostic tests in a clinical setting.
All these factors clearly indicate that the Nano-Check ™AMI 3 IN 1 Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nano-Check ™AMI 3 IN 1 Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl), Creatine Kinase MB (CK-MB), and Myoglobin in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml, 5.0 ng/ml, and 80 ng/ml, respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI).
The Nano-Check™ AMI 3 IN 1 Test is a qualitative assay, which can not monitor the rise and fall of cTnl, CK-MB, and Myoglobin in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other laboratory test results and patient clinical findings.
Product codes (comma separated list FDA assigned to the subject device)
MMI, JHT, DDR
Device Description
The Nano-Check ™ AMI 3 IN 1 Test is a one-step lateral flow immunochromatography assay for the qualitative determination of three cardiac markers simultaneously in serum and heparin plasma. The test is a single-use, visually read, cassette device in a plastic housing. Membrane strip inside the plastic housing contains immobilized molecules at three test lines and one control line; CK-MB antibody, Myoglobin antibody, streptavidine and goat anti-mouse antibody. Dye pad at the end of the membrane strip contains biotinylated cTnl antibody and gold colloidal particles coupled with CK-MM, cTnl and Myoqlobin antibodies. Cutoff level of each marker is 0.5 ng/ml, 5 ng/ml and 80 ng/ml for cTnl. CK-MB and Myoglobin respectively. Device is sealed in pouch with desiccant and provided with instructions for use and disposable sample dropper.
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
Professional use
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)
The following performance characteristics were addressed to support this submission:
- a. Analytical Performance
- Precision/Reproducibility
- Traceability, stability, expected values
- Detection Limit
- Analytical Specificity
- Assay Cut-off
- b. Comparison Studies to Predicate
- Method Comparison with Predicate Device
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
§ 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
2006 MAR 2
510(K) SUMMARY of Nano-Check™ AMI 3 IN 1 Test
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is: _______________________________________________________________________________________________________________________________________________
Submitter's Identification: 1.
Nano-Ditech Co. 11 Deer Park Dr., Suite 118 Monmouth Junction, NJ 08852 Tel: 732-438-8616 Fax: 732-438-8617
Contact: Mr. Thomas Cekoric, Jr. President/CEO
Date Summary Prepared: February 28, 2006
Name of the Device: 2.
Nano-Check™ AMI 3 IN 1 Cardiac Marker Test cTnl, CK-MB and Myoglobin
Common or Usual Name:
Immuno Assay Method, Troponin Subunit, Chromatographic Separation, CPK ISO Enzymes
Predicate Device Information: 3.
Spectral Cardiac STATus™ CK-MB-Myoglobin/Troponin I 3-in-1 test K030057
Spectral Diagnostics Systems 135 The West Mall Toronto, Ontario Canada M9C 1C2
1
4. Device Description:
The Nano-Check ™ AMI 3 IN 1 Test is a one-step lateral flow immunochromatography assay for the qualitative determination of three cardiac markers simultaneously in serum and heparin plasma.
The test is a single-use, visually read, cassette device in a plastic housing. Membrane strip inside the plastic housing contains immobilized molecules at three test lines and one control line; CK-MB antibody, Myoglobin antibody, streptavidine and goat anti-mouse antibody. Dye pad at the end of the membrane strip contains biotinylated cTnl antibody and gold colloidal particles coupled with CK-MM, cTnl and Myoqlobin antibodies. Cutoff level of each marker is 0.5 ng/ml, 5 ng/ml and 80 ng/ml for cTnl. CK-MB and Myoglobin respectively.
Device is sealed in pouch with desiccant and provided with instructions for use and disposable sample dropper.
Test Principle:
The Nano-Check ™ AMI 3 IN 1 Test is an immunochromatography assay for the qualitative determination of three biochemical markers (cTnl, CK-MB and Myoglobin) simultaneously in serum and heparin plasma. The membrane strip contains three test lines and one control line: immobilized monoclonal mouse antibody against CK-MB, monoclonal mouse antibody against Myoglobin, streptavidin for biotinylated cTnl antibody, and goat anti-mouse antibody for control line. A dye pad is placed at the end of the membrane containing biotinylated cTnl antibody and gold colloidal particles coupled with CK-MM, cTnl and Myoqlobin antibodies. When a sample is applied into the sample well, the cardiac makers present in the sample bind to the specific antibodies coupled with gold particles. cTnl in a sample binds to both cTnl specific dye coupled antibody and biotinylated antibody. The immune complexes move along the nitrocellulose membrane through the test lines and bind to their corresponding capture antibodies immobilized on the test line. Unbound immune complexes pass through the test line and are captured by goat anti mouse antibody in the control line.
If the concentration of any of these three markers in the sample is above the cutoff level, red bands appear at the corresponding test lines and the control line. If the concentration of the markers in the sample is lower than the cutoff level, only the colored control line can be seen in the test window.
The control line is an internal control to ensure that an adequate volume of sample has been added. This colored control band must always appear at the control line position (Con) for valid test results. A test result is not valid if the colored control line does not appear in the test window.
2
5. Intended Use:
The Nano-Check ™AMI 3 IN 1 Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl), Creatine Kinase MB (CK-MB), and Myoglobin in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml, 5.0 ng/ml, and 80 ng/ml, respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI).
The Nano-Check™ AMI 3 IN 1 Test is a qualitative assay, which can not monitor the rise and fall of cTnl, CK-MB, and Myoglobin in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other laboratory test results and patient clinical findings.
Comparison to Predicate Devices: 6.
Overall performance and characteristics of the Nano-Check™ AMI 3 IN 1 Test compared to the predicate devices (cited below), are summarized in the table below:
| Item | Device | Predicates |
|---|---|---|
| Nano-Check™ AMI 3 IN 1, | ||
| Cardiac Marker Test, cTnl, CK-MB, and Myoglobin | Spectral Cardiac STATus™ CK-MB-Myoglobin/Troponin I 3-in-1 test | |
| Similarities | ||
| Analyte | cTnl, CK-MB, and Myoglobin | Same |
| Test Principle | Lateral-flow, | |
| immunochromatographic Test | Same | |
| Type of test | Qualitative | Same |
| Assay time | 15 minutes | Same |
| Intended use | Professional use | Same |
| Cutoff | ||
| concentration | cTnl: 0.5 ng/ml | |
| CK-MB: 5 ng/ml | ||
| Myoglobin: 80 ng/ml | Same | |
| Differences | ||
| # test /strip | Multiple (3 tests / strip) | Multiple (3 tests / 2 strips) |
| Capture | ||
| molecule in | ||
| test line | cTnl: Streptavidin | |
| Myo: Monoclonal mouse anti-Myo antibody | cTnl: Streptavidin | |
| Myo: Polyclonal rabbit anti-myo antibodies |
COMPARISON TABLE
3
| | CKMB: Monoclonal mouse anti-
CKMB antibody | CKMB: Polyclonal goat anti-
CKMM antibodies |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Conjugate
molecule | cTnl: Dye coupled with monoclonal
mouse anti-cTnl antibody
and biotinylated monoclonal
mouse anti-cTnl antibody | cTnl: Dye coupled with monoclonal
anti-cTnl antibody and
biotinylated polyclonal rabbit
anti-cTnl antibodies |
| | Myo: Dye coupled with monoclonal
mouse anti-Myo antibody | Myo: Dye coupled with anti-Myo
antibody |
| | CKMB: Dye coupled with
monoclonal mouse anti-
CKMM | CKMB:Dye coupled with
monoclonal mouse anti-
CKMB |
| Sample type | Serum or Plasma (heparin as
anticoagulant) | Whole blood, serum or plasma
(heparin as anticoagulant) |
| Sample
application
volume | 200~250µl in one sample well | Total of 300 µl in two sample wells |
| Storage
temperature | 2-30°C | 15-30°C |
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
The following performance characteristics were addressed to support this submission.
- a. Analytical Performance
- Precision/Reproducibility .
- Traceability, stability, expected values .
- Detection Limit .
- Analytical Specificity .
- Assay Cut-off .
- b. Comparison Studies to Predicate
- Method Comparison with Predicate Device .
8. Discussion of Clinical Tests Performed:
Not Applicable
4
9. Conclusions:
The submitted data for this subject premarket notification supports a substantial equivalence decision for the Nano-Check™ AMI 3 IN 1 Cardiac Marker Test cTnl, CK-MB and Myoglobin, by comparison with the predicate device the Spectral Cardiac STATus™ CK-MB-Myoglobin/Troponin I 3-in-1 test, K030057.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 2006
Nano-Ditech Co. c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
Re: K050975
Trade/Device Name: Nano-Check™ AMI 3 in 1 Cardiac Marker Test cTnl, CK-MB And Myoglobin Regulation Number: 21 CFR§862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JHT, DDR Dated: February 21, 2006 Received: February 22, 2006
Dear Ms. Goldstein-Falk:
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).
6
Page 2 -
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Page 1 of 1
K050975 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Nano-Check™ AMI 3 IN 1 Cardiac Marker Test cTnl, CK-MB and Myoglobin
Indications For Use:
The Nano-Check ™AMI 3 IN 1 Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl), Creatine Kinase MB (CK-MB), and Myoglobin in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml, 5.0 ng/ml, and 80 ng/ml, respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI).
The Nano-Check™ AMI 3 IN 1 Test is a qualitative assay, which can not monitor the rise and fall of cTnl, CK-MB, and Myoglobin in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other laboratory test results and patient clinical findinas.
Prescription Use × (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CAC
Division Sign-Off
Concurrence of SPORH Office at Destice Evaluation (ODE)