The Quantech Myoglobin Assay is intended to be used as an aid in diagnosing myocardial infarction in patients exhibiting chest pain. It is intended to be used in conjunction with EKG, and physician examination, as well as possibly other biochemical blood tests to rule in or out non-cardiac damaging origin of the chest pain.

Device Description

The Quantech Myoglobin Assay is based on the principle of two site, or sandwich immunoassay in combination with SPR surface mass measurement. Each test module contains a solid phase anti-myoglobin monoclonal antibody immobilized onto a gold surface. An anti-myoglobin enzyme conjugate solution and wash solution are used to enhance the specific detection of myoglobin.

The Quantech assay utilizes myoglobin-specific antibody to capture the myoglobin in the sample. This is followed by a quantitation of the surface mass increase using surface plasmon resonance (SPR), to measure the myoglobin in serum.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Quantech Myoglobin Assay based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test Description	Reported Device Performance
Non-Clinical Performance	Dilution Linearity/Parallelism	Average % of expected: 107% (individuals 101-115%)
	Recovery	Average recovery: 108%
	Analytical Sensitivity	6 ng/mL
	Precision (Intra-assay)	Low: 61 (11.9% CV), Medium: 131 (9.7% CV), High: 378 (9.5% CV) ng/mL
	Precision (Inter-assay)	Low: 51 (7.1% CV), Medium: 110 (6.2% CV), High: 219 (10.3% CV) ng/mL
	Interfering Substances	Acceptable recovery in presence of bilirubin, triglycerides, hemoglobin (no interference noted)
	Hook Effect	No high dose hook effect observed up to 10,000 ng/mL
Clinical Performance	Normal Range (Male)	16-70 ng/mL (consistent with published literature 19-92 ng/mL)
	Normal Range (Female)	17-55 ng/mL (consistent with published literature 12-76 ng/mL)
	Overall Normal Range	14-70 ng/mL
	Patient Sample Correlation (vs. predicate)	Correlation coefficient: 0.970 (slope = 1.16, y-intercept = 7.94 ng/mL)

Note on Acceptance Criteria: The document describes the "Summary of Non-Clinical Performance Data" and "Summary of Clinical Performance Data" but does not explicitly state pre-defined acceptance criteria in numerical terms (e.g., "Recovery must be between 90-110%"). Instead, it presents the results of these performance tests, implying these results met the internal criteria for substantial equivalence to the predicate device.

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

Non-Clinical Performance:
- Dilution Linearity/Parallelism: "Serum samples were separately spiked with myoglobin and serially diluted..." - Specific sample size not provided.
- Recovery: Not explicitly stated.
- Analytical Sensitivity: "Multiple duplicates of zero samples (blank) were assayed..." - Specific number of duplicates not provided.
- Precision:
  - Intra-assay: "replicate evaluation of three levels of sera in one day." - Specific number of replicates not provided.
  - Inter-assay: "evaluating three pools (different from INTRAASSAY pools) in multiplicate on different days." - Specific number of replicates/days not provided.
- Interfering Substances: "spiking a serum pool of myoglobin with bilirubin, triglycerides and hemoglobin..." - Specific sample size not provided (likely a small number of spiked samples).
- Hook Effect: "Samples well beyond the standard curve range were assayed." - Specific sample size not provided.
Clinical Performance:
- Normal Range: "Testing of apparently healthy individuals demonstrated a normal range..." - Specific number of individuals not provided.
- Patient Sample Correlation: "Results from human samples with values distributed throughout the quantitative range of the Quantech MYOGLOBIN Assay, were compared..." - Specific number of human samples not provided.
Data Provenance: The document does not specify the country of origin for the data. The studies appear to be conducted by Quantech Ltd., located in St. Paul, MN, USA. There is no indication whether the data is retrospective or prospective. It is implied to be prospective testing for device validation.

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

This device is an in-vitro diagnostic (IVD) assay for measuring myoglobin in serum. The 'ground truth' for such a device is typically established through a reference method or known concentrations, rather than expert interpretation of images or clinical findings.
For the patient sample correlation, the Quantech Myoglobin Assay results were compared to a "commercially available method (fluorogenic ELISA)," which serves as the comparative reference. The expert involvement here would be in running and interpreting the reference method, but no specific number of experts or their qualifications are mentioned.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for an IVD assay. Adjudication methods (like 2+1 or 3+1) are typically used in image-based diagnostic studies where human experts interpret medical images.
For this assay, "ground truth" for non-clinical performance (e.g., analytical sensitivity, precision) is determined by laboratory standards and established measurement methodologies. For clinical correlation, the predicate device/method serves as the reference, and agreement is measured statistically (correlation coefficient).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve significant human interpretation, such as radiology AI tools.
This submission is for an IVD assay, where the output is a quantitative measurement, not an interpretation that varies significantly between human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Yes, the performance data presented (Dilution Linearity, Recovery, Analytical Sensitivity, Precision, Interfering Substances, Hook Effect, Normal Range, Patient Sample Correlation) reflects the standalone performance of the Quantech Myoglobin Assay itself. As an IVD kit, it provides a quantitative result without direct human intervention or interpretation of the assay's output to reach the result.
The device design inherently focuses on standalone algorithm performance to generate a quantitative myoglobin value.

7. Type of Ground Truth Used

For non-clinical performance (e.g., linearity, recovery, sensitivity, precision, interference, hook effect):
- Known concentrations/spiked samples: Myoglobin was added to samples at known levels to assess linearity, recovery, and other analytical characteristics.
- Reference standards/blanks: Used for analytical sensitivity determination.
For clinical performance (normal range, patient correlation):
- Biologically established ranges: The normal range was determined by testing "apparently healthy individuals" and compared to "published literature."
- Comparative method/Predicate device results: For patient sample correlation, the "commercially available method (fluorogenic ELISA)" served as the reference standard to which the Quantech assay results were compared.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its size.
This type of IVD device (sandwich immunoassay with SPR measurement) is typically developed using chemical and biological principles and optimization, rather than machine learning models that require distinct training sets. The development process likely involves extensive experimentation to optimize reagents, concentrations, and reaction conditions, but this is distinct from the concept of a "training set" in AI/ML contexts.

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

As no training set is mentioned or applicable in the context of this traditional immunoassay device, this information is not provided and is likely not relevant to its development.

Summary

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K981536

510(k) SUMMARY
Revision 02

Contact Information

Robin J. Hellen, M.S. Hellen Professional Services (818) 709-5646

Product Name

Classification Name: Trade Name: Common Name:

Myoglobin Immunological Test System, Class II Quantech Myoglobin Assay Mvoalobin Test Kit

· Substantial Equivalence

The Quantech Myoglobin Assay is substantially equivalent to the OPUS® Myoglobir assay marketed by Behring Diagnostics Inc. since 1991.

Intended Use

Device Description

The Quantech assay utilizes myoglobin-specific antibody to capture the myoglobin in the This is followed by a quantitation of the surface mass increase using surface sample. plasmon resonance (SPR), to measure the myoglobin in serum.

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Comparison of Technological Characteristics

The Quantech Myoglobin Assay is similar to the Opus® Myoglobin assay (K915850) as follows. Both assays are in vitro immunological assays for the quantitative measurement of human myoglobin. Additionally, both assays use antibody to myoglobin coated on a solid support, and both instruments utilize a microprocessor for instrument control, data acquisition, and data reduction.

Summary of Non-Clinical Performance Data

Dilution Linearity/Parallelism - The parallelism study was conducted to evaluate the linearity of the Quantech MYOGLOBIN Assay. Serum samples were separately spiked with myoglobin and serially diluted with corresponding unspiked serum. The average percent of expected was 107% with individuals varying from 101-115%.

Recovery - Accuracy of the Quantech MYOGLOBIN Assay was calculated from test results as the percentage of added analyte, corrected for endogenous analyte, recovered by the assay. After correcting for endogenous myoglobin content, the average recovery was 108%.

Analytical Sensitivity - Multiple duplicates of zero samples (blank) were assayed to determine the minimum quantity of myoglobin detectable by the Quantech Assay. The average SPR signal shift plus two standard deviations (2 S.D.) was calculated and translated into a dose. The calculated analytical sensitivity of the Quantech myoglobin assay is 6 ng/mL.

Precision - INTRAASSAY variation was calculated by replicate evaluation of three levels of sera in one day. The mean mvoolobin concentrations (with % C.V.) were 61 (11.9%), 131 (9.7%), and 378 (9.5%) ng/mL for the low, medium and high pools, respectively.

The INTERASSAY precision was determined by evaluating three pools (different from INTRAASSAY pools) in multiplicate on different days. The mean myoglobin concentrations (with % C.V.) were 51 (7.1%), 110 (6.2%), and 219 (10.3%) ng/mL for the low, medium and high pools, respectively.

Interfering Substances - Physiological interference was evaluated by spiking a serum pool of myoglobin with bilirubin, triglycerides and hemoglobin at levels ten times the highest expected physiological concentration. The percent recovery of myoglobin was determined to be acceptable in all three solutions and no interference was noted by the endogenous in the Quantech Myoglobin assay.

Hook Effect - Samples well beyond the standard curve range were assayed. No high dose hook effect was observed. Therefore, the Quantech Myoglobin Assay does not give erroneously low results for grossly elevated samples up to at least 10,000 ng/ml.

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Summary of Clinical Performance Data

Normal Range - Testing of apparently healthy individuals demonstrated a normal range consistent with published literature (male 19-92 ng/mL and female 12-76 ng/mL). The overall normal range observed with the Quantech MYOGLOBIN assay was 14-70 ng/mL with 16-70 ng/mL for males and 17-55 ng/mL observed for females.

Patient Sample Correlation - Results from human samples with values distributed throughout the quantitative range of the Quantech MYOGLOBIN Assay, were compared with those obtained with a commercially available method (fluorogenic ELISA). The correlation coefficient was 0.970 (slope = 1.16, y-intercept = 7.94 ng/mL).

Conclusions Drawn From Performance Tests

The Quantech Myoglobin Assay provides results which are internally accurate, unaffected by ordinary variation of sample matrix and equivalent to the results obtained using the approved device in a valid laboratory setting.

Additionally, both clinically-based studies (normal range, patient correlation) demonstrated essential equivalence between the two devices as measured by their correlation and the degree to which assay results are linearly related to one another over a broad range of values. Likewise, the normal range evaluation provided empirical evidence that the log of the assay value is statistically similar for both devices, and in agreement with published data.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 9 1000

Quantech, Ltd. C/O Robin J. Hellen, M.S. Hellen Professional Services 9418 Lasaine Avenue Northridge, California 91325

K981536 Re : Quantech Myoglobin Assay Regulatory Class: II Product Code: DRD April 28, 1998 Dated: Received: April 29, 1998

Dear Ms. Hellen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DUANTECH MYOGLOBIN ASSAY emarket Notification

PART I - 510(k) Information

Statement for Indications for Use 111.

510(k) Number (if known): K981536

Device Name: Quantech Myoglobin Assay

Indications for Use:

The Quantech Myoglobin Assay is intended to be used as an aid in
diagnosing myocardial infarction in patients exhibiting chest pain. It is
intended to be used in conjunction with EKG, and physician examination,
as well as possibly other biochemical blood tests to rule in or out non-
cardiac damaging origin of the chest pain.

Concurrence of the CDRH, Office of Device Evaluat=ion (ODE)

Prescription Use: ✓

Over the Counter Use: __

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981536

Regulation Number and Section

§ 866.5680 Myoglobin immunological test system.

(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).

Company Information

Contact Information

Product Name

· Substantial Equivalence

Intended Use

Device Description

Comparison of Technological Characteristics

Summary of Non-Clinical Performance Data

Summary of Clinical Performance Data

Conclusions Drawn From Performance Tests

Statement for Indications for Use 111.

§ 866.5680 Myoglobin immunological test system.