The Quantech CK-MB 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 origin of the chest pain.

The Quantech CK-MB Assay is intended to be used for the quantitative determination of the cardiac isoenzyme CK-MB, in order to assist in the diagnosis of acute myocardial infarction.

Device Description

The Quantech CK-MB assay is based on the principle of two site, or sandwich immunoassav in combination with SPR surface mass measurement. Each test module contains a solid phase anti-CK-MB monoclonal antibody immobilized onto a gold surface. An anti-CK-MB polyclonal antibody, used to enhance the specific detection of the isoenzyme is introduced sequentially.

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

AI/ML Overview

The provided text describes the Quantech CK-MB Assay, an in vitro immunological assay for the quantitative measurement of human CK-MB, intended to aid in diagnosing myocardial infarction. The submission seeks substantial equivalence to the AxSYM® CK-MB assay.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values in a table. Instead, it presents performance data and concludes that the device's performance is "acceptable" or "demonstrates essential equivalence" to the predicate device. The "accepted value for cardiac damage" is mentioned as "greater than 7.0 ng/mL CK-MB", which can be considered a clinical threshold, but not a specific acceptance criterion for the device's technical performance.

Here's a summary of the reported device performance:

Performance Metric	Reported Device Performance (Quantech CK-MB Assay)
Dilution Linearity/Parallelism	Average percent of expected: 118% (deemed acceptable)
Recovery	Average recovery: 103% (corrected for endogenous analyte; deemed acceptable)
Analytical Sensitivity	0.3 ng/mL
Precision (INTERASSAY)	Low pool (37.5 ng/mL): 9.4% CV; Medium pool (83.1 ng/mL): 4.8% CV; High pool (149 ng/mL): 7.0% CV
TOTAL IMPRECISION	Low pool (37.5 ng/mL): 13.3% CV; Medium pool (83.1 ng/mL): 9.1% CV; High pool (149 ng/mL): 10.1% CV
Interfering Substances	Percent recovery of CK-MB determined to be acceptable in all three solutions (hemoglobin, bilirubin, triglycerides); no interference noted.
Hook Effect	No high dose hook effect observed up to at least 5,000 ng/mL.
Normal Range (vs. predicate)	Performs similarly at and below 7.0 ng/mL CK-MB. 95% limit of normals: 4.2 ng/mL (vs. predicate's 3.8 - 6.5 ng/mL). No false positives.
Patient Sample Correlation	Correlation coefficient: 0.95 (slope = 0.81, y-intercept = 0.37 ng/mL) with a commercially available method (fluorogenic ELISA).

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

Test Set Sample Size: The document does not explicitly state the exact sample size for the clinical test sets.
- For the "Normal Range" study, it mentions "Testing of apparently healthy individuals" and "samples containing high levels of either RF or HAMA". The specific number of individuals or samples is not provided.
- For "Patient Sample Correlation", it mentions "Results from human samples with values distributed throughout the quantitative range". The specific number of human samples is not provided.
Data Provenance: The document does not specify the country of origin of the data. It implies the data is retrospective as it compares the new device with an existing "predicate device" (AxSYM® CK-MB assay marketed by Abbott Laboratories since 1993) and a "commercially available method (fluorogenic ELISA)".

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

Not applicable. This device is an in vitro diagnostic (IVD) assay for measuring a biochemical marker (CK-MB levels). The "ground truth" for the test set is the actual CK-MB concentration in the samples, determined by reference methods or the predicate device, not by expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set

Not Applicable. As an IVD assay, the ground truth is established by the concentration of the analyte, not by expert consensus requiring adjudication. Comparisons are made against the predicate device or a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an IVD assay, not an AI-assisted diagnostic imaging or clinical decision support tool that involves human readers. Therefore, an MRMC study and effect size on human readers are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are standalone performance evaluations of the Quantech CK-MB Assay itself. The performance data (linearity, recovery, sensitivity, precision, interference, hook effect, normal range comparison, and patient sample correlation) all represent the direct output of the algorithm/device without explicit human intervention in the result generation or interpretation phase beyond standard laboratory procedures for operating the instrument and collecting samples.

7. The Type of Ground Truth Used

The ground truth for the performance studies was:

Reference measurements/Predicate Device: For "Normal Range" and "Patient Sample Correlation," the Quantech CK-MB Assay's results were compared against the AxSYM® CK-MB assay (predicate device) and a "commercially available method (fluorogenic ELISA)". The predicate device's established values and the results from the alternative commercial method served as the comparative "truth".
Known Spiked Concentrations: For "Dilution Linearity/Parallelism" and "Recovery", samples were "spiked with CK-MB" at known concentrations.
Stripped Plasma: For "Analytical Sensitivity", "zero samples (stripped plasma)" were used to determine the minimum detectable quantity, implying a known absence of the analyte.
Physiological Interference: For "Interfering Substances", known levels of interferents (hemoglobin, bilirubin, triglycerides) were added to CK-MB samples.

8. The Sample Size for the Training Set

The document does not provide information on a specific "training set" or its sample size. This type of regulatory submission for an IVD assay typically focuses on validation and verification studies rather than machine learning model training. The assay relies on established immunoassay principles, not a learnable algorithm that requires a separate training set.

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

Not applicable, as a distinct "training set" for a machine learning algorithm is not described or implied for this device. The development of the assay itself would have involved internal optimization and calibration using reference materials and characterized samples, but this is distinct from a machine learning training set.

Summary

{0}------------------------------------------------

K984433

CK-MB ASSAY

PREMARKET NOTIFICATION
[510(K)]

SAFETY AND EFFECTIVENESS SUMMARY
(ATTACHMENT)

1419 Energy Park Drive, St. Paul, Minnesota (612) 647-6370

{1}------------------------------------------------

QUANTECH CK-MB ASSAY

510(k) SUMMARY

Contact Information

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

Product Name

Classification Name: Creatine Kinase (CK) or Isoenzymes Test Systems, Class II Trade Name: Quantech CK-MB Assay Common Name: CK-MB Test Kit

CLIA Categorization

We believe the Quantech CK-MB Assay to be moderately categorized based on previous classification of analogous tests.

Substantial Equivalence

The Quantech CK-MB Assay is substantially equivalent to the AxSYM® CK-MB assay marketed by Abbott Laboratories since 1993.

Intended Use

{2}------------------------------------------------

Device Description

Comparison of Technological Characteristics

The Quantech CK-MB Assay is similar to the AxSYM® CK-MB assay as follows. Both assays are in vitro immunological assays for the quantitative measurement of human CK-MB. Additionally, both assays use antibody to CK-MB 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 CK-MB Assay. Plasma samples were separately spiked with CK-MB and serially diluted with corresponding unspiked serum. The average percent of expected was 118%.

Recovery - Accuracy of the Quantech CK-MB Assay was calculated from test results as the percentage of added analyte, corrected for endogenous analyte, recovered by the assay. After correcting for endogenous CK-MB content, the average recovery was 103%.

Analytical Sensitivity - Multiple duplicates of zero samples (stripped plasma) were assaved to determine the minimum quantity of CK-MB detectable by the Quantech Assay. The average SPR signal shift plus two standard deviations (2 S.D.) was caleulated into a dose. The calculated analytical sensitivity of the Quantech CK-MB assay is 0.3 ng/mL.

Precision - The INTERASSAY precision was determined by evaluating three pools in triplicate on different days. The mean CK-MB concentrations (with % C.V.) were 37.5 (9.4%), 83.1 (4.8%), and 149 (7.0%) ng/mL for the low, medium and high pools, respectively.

TOTAL IMPRECISION was determined from the interassay data, and is a combination of results from multiple runs on multiple days. The mean CK-MB concentrations (with % C.V.) were 37.5 (13.3%), 83.1 (9.1%), and 149 (10.1%) ng/mL for the low, medium and high pools, respectively.

{3}------------------------------------------------

510(k) SUMMARY

Summary of Non-Clinical Performance Data (Cont.)

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

Hook Effect - Samples well beyond the standard curve range were assaved. No high dose hook effect was observed. Therefore, the Quantech CK-MB Assay does not give erroneously low results for grossly elevated samples up to at least 5,000 ng/mL.

Summary of Clinical Performance Data

Normal Range - Testing of apparently healthy individuals demonstrated that the Quantech CK-MB Assay and the predicate device perform similarly at and below the accepted value for cardiac damage (greater than 7.0 ng/mL CK-MB). Both methods are also compatible with published expected values. The 95% limit of normals as referenced in the predicate device insert is 3.8 vs. 6.5 ng/mL found herein, and 4.2 ng/mL found for the Quantech CK-MB assay. Both methods yielded a male mean which was higher than that of females, which is clinically characteristic of the CK-MB assay. Further demonstrating equivalence, samples containing high levels of either RF or HAMA assayed within the expected range on both methods.

The Quantech device demonstrates no false positive results with these apparently healthy individuals and is in 100% agreement with the predicate device.

Patient Sample Correlation - Results from human samples with values distributed throughout the quantitative range of the Quantech CK-MB, were compared with those obtained with a commercially available method (fluorogenic ELISA). The correlation coefficient was 0.95 (slope = 0.81, y-intercept = 0.37 ng/mL).

Conclusions Drawn From Performance Tests

The Quantech CK-MB 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.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings, symbolizing strength and freedom. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle, indicating the department's name and national affiliation. The logo is simple, clean, and easily recognizable.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 1 1999

Quantech, Ltd. c/o Ms. Robin J. Hellen, M.S. Hellen Professional Services 9418 Lasaine Avenue Northridge, California 91325

Re: K984433 Trade Name: Ouantech CK-MB Assay Regulatory Class: II Product Code: MYT Dated: August 30, 1999 Received: August 31, 1999

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. 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 Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements 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 regulations.

{5}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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 "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

{6}------------------------------------------------

QUANTECH CK-MB/ASSAY - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

PART I - 510(k) Information

Statement for Indications for Use lll.

984433510(k) Number (if known):
Quantech CK-MB AssayDevice Name:	(Division Sign-Off)Division of Clinical Labora:
Indications for Use:	510(k) Number_K 984433
The Quantech CK-MB Assay is intended to be used for the quantitativedetermination of the cardiac isoenzyme CK-MB, in order to assist in thediagnosis of acute myocardial infarction.Concurrence of the CDRH, Office of Device Evaluation (ODE)

	1
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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.

QUANTECH CK-MB ASSAY

Company Information

Contact Information

Product Name

CLIA Categorization

Substantial Equivalence

Intended Use

Device Description

Comparison of Technological Characteristics

Summary of Non-Clinical Performance Data

Summary of Non-Clinical Performance Data (Cont.)

Summary of Clinical Performance Data

Conclusions Drawn From Performance Tests

Page 2

Statement for Indications for Use lll.

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.