QUANTEX MYOGLOBIN

K042982 · Instrumentation Laboratory CO · DDR · Dec 22, 2004 · Immunology

Device Facts

• Record ID: K042982
• Device Name: QUANTEX MYOGLOBIN
• Applicant: Instrumentation Laboratory CO
• Product Code: DDR · Immunology
• Decision Date: Dec 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

Quantex 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. 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.

Device Story

Quantex Myoglobin is an in vitro diagnostic assay used on clinical chemistry systems (e.g., ILAB600) to measure myoglobin concentration in human serum or plasma. The device utilizes a latex particle-enhanced immunoturbidimetric principle; rabbit IgG anti-human myoglobin-coated polystyrene latex particles react with myoglobin in the patient sample. This reaction causes agglutination, which is measured as a decrease in transmitted light proportional to myoglobin concentration. The system includes a buffer reagent, latex reagent, multipoint calibration standards, and quality controls. It is operated by laboratory personnel in a clinical setting. The output is a quantitative myoglobin value, which clinicians use as an aid in the diagnosis of myocardial infarction. The device provides automated rerun capabilities for samples exceeding the linear range to ensure accurate quantification.

Clinical Evidence

Bench testing only. Precision assessed per NCCLS EP5-A (Total %CV 1.9-2.3%). Linearity validated across 10-5000 ng/mL range (R^2 > 0.99). Analytical specificity confirmed no significant interference from lipemia, bilirubin, hemoglobin, or common cross-reactants. Method comparison with predicate (n=67) showed high correlation (R^2=0.997, slope 0.99). Reference ranges established using 360 healthy donors.

Technological Characteristics

Latex particle-enhanced immunoturbidimetric assay. Reagents: polystyrene latex particles coated with rabbit IgG anti-human myoglobin. Energy source: clinical chemistry analyzer light source (photometric measurement). Connectivity: standalone reagent kit for use on clinical chemistry systems. Sterilization: N/A (reagents). Software: embedded instrument software for automated measurement, dilution, and calculation.

Indications for Use

Indicated for the quantitative determination of myoglobin in human serum or plasma (EDTA or Lithium Heparin) to aid in the diagnosis of myocardial infarction. For in vitro diagnostic use.

Regulatory Classification

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.

Predicate Devices

• N Latex Myoglobin (k902154)

Reference Devices

• quantex Ferritin (K040879)

Submission Summary (Full Text)

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## 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: [phone] Fax:

## Contact Person:

Carol Marble, Regulatory Affairs Director Phone: [phone] / Fax: [phone]

#### 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):

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.

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.

## 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

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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).

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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

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# Indications for Use Statement

510(k) Number (if known): _

Device Name: quantex Myoglobin

## Indications for Use:

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.

Prescription Use
(Part 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)

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

Carol C. Benam
Division Sign-Off

Office or in Vilm Diricinostic

810(k) K042982