Ouantex Myoglobin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of myoglobin concentration in human serum or plasma (EDTA or Lithium Heparin) on Clinical Chemistry Systems as an aid in the diagnosis of myocardial infarction. For in vitro diagnostic use.

Ouantex Ferritin / Myoglobin controls I/II are intended for use in monitoring the quality control of results obtained with the quantex Myoglobin reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879.) For in vitro diagnostic use.

Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.

Device Description

Quantex Ferritin / Myoglobin controls I/II are intended for use in monitoring the quality control of results obtained with the quantex Myoglobin reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879.) For in vitro diagnostic use.

Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the quantex Myoglobin device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly Derived from Predicate)	Reported Device Performance
Method Comparison	Strong correlation with predicate device (N Latex Myoglobin)	Slope: 0.99, Correlation Coefficient (r): 0.999
Precision (Within-Run)	Low coefficient of variation (CV)	1.1% CV (at 71.4 ng/ml myoglobin) 1.3% CV (at 229 ng/ml myoglobin)

Note: The document focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are not explicitly stated as numerical targets but are inferred from the performance of the predicate device and what is considered acceptable for such assays. The reported device performance metrics are presented to show the new device meets or exceeds these implied standards.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 67 samples
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) summary for a US FDA submission, it is likely that the data was generated within a controlled, possibly clinical, setting. It is not specified if the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This device is an in vitro diagnostic assay for a quantitative measurement (myoglobin concentration), not an imaging or diagnostic AI requiring expert interpretation of ground truth. Its performance is compared to a reference method (the predicate device) or internal quality control standards.
Adjudication method for the test set:
- Not applicable/Not mentioned. As this is a quantitative measurement, the "ground truth" for the method comparison study is the result obtained from the predicate device, or the mean of multiple measurements for precision. Adjudication by multiple experts is not relevant here.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a diagnostic assay for quantitative determination of myoglobin, not an AI-assisted diagnostic tool that aids human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance data presented (method comparison and precision) represents the standalone performance of the quantex Myoglobin assay system. There is no human-in-the-loop component described for its basic operation as a laboratory test.
The type of ground truth used:
- For the method comparison study, the "ground truth" was established by the predicate device's measurements (N Latex Myoglobin). The new device's results were compared against these established values.
- For precision, the "ground truth" (or target values) were the mean concentration levels of the quality control materials (quantex Ferritin/Myoglobin controls I/II).
The sample size for the training set:
- Not applicable/Not mentioned. This device is a traditional immunoturbidimetric assay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The development of such an assay involves analytical validation, not model training.
How the ground truth for the training set was established:
- Not applicable. As there is no "training set" in the context of an AI/ML device, this question is not relevant. The assay's analytical characteristics are developed and verified through standard laboratory procedures and calibration.

Summary

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

DEC 2 2 2004

Section 3 quantex Myoglobin 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:

Contact Person:

Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

October 28, 2004

Name of the device:

quantex Myoglobin

Classification name(s):

866.5680	Myoglobin Immunological Test System	Class II
DDR	Myoglobin, Antigen, Antiserum, Control

Identification of predicate device(s):

K902154 N Latex Myoglobin (Dade Behring)

Description of the device/intended use(s):

Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

Ouantex Myoglobin is substantially equivalent to the commercially available predicate device, N Latex Myoglobin, in performance and intended use.

Summary of Performance Data:

In a method comparison study evaluating 67 samples with myoglobin levels ranging from 16 to 2070 ng/ml on an ILab 600, the slope was 0.99 and the correlation coefficient (r) was 0.999 for quantex Myoglobin versus the predicate device.

Within run precision assessed over multiple runs using quantex Ferritin/Myoglobin controls I/II on an ILab 600 gave a CV of 1.1% (at a mean of 71.4 ng/ml) and 1.3% (at a mean of 229 ng/ml).

quantex Myoglobin - K042982

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 22 2004

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, MA 02421-3125

K042982 Re:

Trade/Device Name: quantex Myoglobin Regulation Number: 21 CFR 866.5680 Regulation Name: Myoglobin immunological test system Regulatory Class: Class II Product Code: DDR, JIT, JJX Dated: October 28, 2004 Received: October 29, 2004

Dear Ms. Marble:

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).

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

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 (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,

Cornelia B. Lorke

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

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

Indications for Use Statement

510(k) Number (if known): _

Device Name: quantex Myoglobin

Indications for Use:

Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.

Prescription Use
(Part 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)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benam
Division Sign-Off

Office or in Vilm Diricinostic

810(k) K042982

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).