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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Nano-Check™ AMI 3 IN 1 Test, which is a qualitative immunochromatography assay for cardiac markers. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in a clinical trial report for AI/CADe devices.

Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity/AUC, detailed ground truth establishment for training, and training set size) is not present in this document. This submission primarily relies on "analytical performance" and "method comparison" studies, not complex clinical effectiveness studies with human readers or large-scale AI validation.

Here's a summary of what can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" as clear numerical thresholds for performance metrics. Instead, it refers to "overall performance and characteristics" and "analytical performance" being addressed to support substantial equivalence. The "performance" is demonstrated by addressing analytical characteristics and comparing them to a predicate device.

Performance Characteristic	Acceptance Criteria (Not explicitly stated as numerical targets)	Reported Device Performance
Qualitative Determination	Ability to detect cTnl, CK-MB, Myoglobin at specified cutoffs	Demonstrated via Analytical Performance and Method Comparison (details not provided)
Cutoff Concentration	Matching predicate device cutoffs	cTnl: 0.5 ng/mlCK-MB: 5 ng/mlMyoglobin: 80 ng/ml
Assay Time	Matching predicate device assay time	15 minutes
Analyte	Detection of cTnl, CK-MB, Myoglobin	Same as predicate (cTnl, CK-MB, and Myoglobin)
Test Principle	Lateral-flow, immunochromatographic Test	Same as predicate
Type of Test	Qualitative	Same as predicate
Intended Use	Professional use, aid in AMI diagnosis	Same as predicate
Precision/Reproducibility	(Implicitly, to be within acceptable limits for IVD)	Addressed (details not provided)
Traceability, Stability, Expected Values	(Within acceptable limits for IVD)	Addressed (details not provided)
Detection Limit	(Within acceptable limits for IVD)	Addressed (details not provided)
Analytical Specificity	(Within acceptable limits for IVD)	Addressed (details not provided)
Assay Cut-off	(Established and validated)	Addressed, 0.5 ng/ml cTnl, 5 ng/ml CK-MB, 80 ng/ml Myoglobin

2. Sample Size for the Test Set and Data Provenance:

Sample Size: Not specified in the provided summary. The document mentions "Method Comparison with Predicate Device" and "Analytical Performance" studies, but does not provide the number of samples used in these non-clinical tests.
Data Provenance: Not specified. Given it's a 510(k) for an IVD, these stability and analytical studies are typically conducted at the manufacturer's site or contracted labs. Country of origin for data is not mentioned.
Retrospective/Prospective: Not specified, but analytical and method comparison studies are often conducted using banked samples (retrospective) or spiked samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not Applicable. This device is a diagnostic assay (an IVD) run on a sample (serum/plasma), not an imaging AI device that relies on expert interpretation for ground truth. The "ground truth" for such assays is established through reference methods (e.g., highly accurate laboratory analyzers) and spiked samples with known concentrations. The summary does not involve human readers interpreting images.

4. Adjudication Method for the Test Set:

Not Applicable. See point 3. This is an in-vitro diagnostic device, not an AI/CADe system requiring human adjudication of interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No. An MRMC study is not mentioned or implied because this is an in-vitro diagnostic test. These studies are relevant for imaging devices where human readers interpret medical images with and without AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

Yes, implicitly. The entire device is the "algorithm only" in the context of its function as an IVD. It's a qualitative test that produces a visual result (red bands) indicating the presence or absence of cardiac markers above a cutoff. Its performance is evaluated through analytical studies (precision, accuracy relative to reference, detection limit, specificity, etc.) which collectively represent its standalone performance characteristics. However, detailed results of these studies (e.g., sensitivity, specificity derived from analytical studies) are not provided in this summary.

7. The Type of Ground Truth Used:

For analytical performance studies (Detection Limit, Analytical Specificity, Assay Cut-off), the ground truth would typically be established using:
- Known concentrations: Samples (serum/plasma) spiked with known, precise concentrations of cTnl, CK-MB, and Myoglobin.
- Reference methods: Comparison against established, high-accuracy laboratory reference assays for these cardiac markers.
- Clinical correlation: While not a direct "ground truth" for the device's output, the overall utility is "as an aid in the diagnosis of Acute Myocardial Infarction (AMI)," implying that the presence of these markers above the cutoff correlates with AMI, which would be pathology-confirmed or clinically adjudicated. However, the study supporting this 510(k) focused on analytical performance and comparison to a predicate, not clinical outcomes directly.

8. The Sample Size for the Training Set:

Not Applicable/Not Specified. This device is a lateral-flow immunochromatographic assay, not a machine learning or AI model that requires a distinct "training set" in the conventional sense. Its "training" is inherent in the chemical and manufacturing process design to ensure appropriate binding and visual signaling at the defined cutoffs.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable/No training set in the conventional sense. As explained in point 8, this device doesn't have a "training set" like an AI algorithm. The assay's "truth" (i.e., its ability to correctly identify positive/negative samples) is built into its biochemical design and validated through analytical studies, as outlined in section 7a.

Summary

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K050975

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

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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.

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.

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5. Intended Use:

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
Cutoffconcentration	cTnl: 0.5 ng/mlCK-MB: 5 ng/mlMyoglobin: 80 ng/ml	Same
Differences
# test /strip	Multiple (3 tests / strip)	Multiple (3 tests / 2 strips)
Capturemolecule intest line	cTnl: StreptavidinMyo: Monoclonal mouse anti-Myo antibody	cTnl: StreptavidinMyo: Polyclonal rabbit anti-myo antibodies

COMPARISON TABLE

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	CKMB: Monoclonal mouse anti-CKMB antibody	CKMB: Polyclonal goat anti-CKMM antibodies
Conjugatemolecule	cTnl: Dye coupled with monoclonalmouse anti-cTnl antibodyand biotinylated monoclonalmouse anti-cTnl antibody	cTnl: Dye coupled with monoclonalanti-cTnl antibody andbiotinylated polyclonal rabbitanti-cTnl antibodies
	Myo: Dye coupled with monoclonalmouse anti-Myo antibody	Myo: Dye coupled with anti-Myoantibody
	CKMB: Dye coupled withmonoclonal mouse anti-CKMM	CKMB:Dye coupled withmonoclonal mouse anti-CKMB
Sample type	Serum or Plasma (heparin asanticoagulant)	Whole blood, serum or plasma(heparin as anticoagulant)
Sampleapplicationvolume	200~250µl in one sample well	Total of 300 µl in two sample wells
Storagetemperature	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

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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.

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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).

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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

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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:

Prescription Use × (Per 21 CFR 801 Subpart D)

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)

K050975

Regulation Number and Section

§ 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.