MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244

Q: Who is the manufacturer of MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244?

Beckman Coulter, Inc. filed the 510(k) submission for MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 (K021229).

Q: What is the FDA product code for MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244?

DDR. It is classified under 21 CFR 866.5680 as a Class 2 device in the Immunology panel.

Q: What is the regulatory pathway for MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244?

Access® Myoglobin Beckman Coulter Inc. Chaska, MN 55416 (K000196).

Q: Who can help prepare an FDA 510(k) submission like MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K021229 · Beckman Coulter, Inc. · DDR · Jun 28, 2002 · Immunology

Device Facts

Record ID	K021229
Device Name	MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
Applicant	Beckman Coulter, Inc.
Product Code	DDR · Immunology
Decision Date	Jun 28, 2002
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5680
Device Class	Class 2

Intended Use

The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.

Device Story

The Access Myoglobin assay is an in vitro diagnostic test used on the Access Immunoassay Systems to measure cardiac myoglobin levels in human serum and plasma. The device utilizes a two-site immunoenzymatic 'sandwich' assay principle. Patient samples are reacted with mouse monoclonal anti-myoglobin-alkaline phosphatase conjugate, mouse monoclonal anti-myoglobin-biotin conjugate, and paramagnetic particles coated with goat anti-biotin. The system employs a dioxetane-based chemiluminescent substrate to measure light production, which is proportional to the myoglobin concentration in the sample. The assay is performed in a clinical laboratory setting by trained personnel. Results are provided to healthcare providers to assist in the rapid diagnosis of heart and renal disease, facilitating timely clinical decision-making for patients presenting with relevant symptoms.

Clinical Evidence

Bench testing only. Analytical studies included precision (within-run 1.58-2.20% CV, total 3.03-4.54% CV), analytical sensitivity (<1.0 ng/mL), and linearity (93% average recovery). Method comparison against the predicate device using 148 samples showed good agreement (Y=1.113X + 15.903, R=0.997). Specificity testing showed no significant interference from drugs or biological substances. Reference intervals were established for serum/lithium heparin and EDTA plasma samples.

Technological Characteristics

Paramagnetic particle-based chemiluminescent immunoassay. Uses mouse monoclonal anti-myoglobin antibodies conjugated to alkaline phosphatase and biotin. Detection via dioxetane-based chemiluminescent substrate. System is an automated immunoassay analyzer. Calibrators are liquid frozen bovine serum albumin-based. No specific ASTM standards cited.

Indications for Use

Indicated for the quantitative determination of cardiac myoglobin in human serum and plasma to aid in the rapid diagnosis of heart and renal disease. For prescription use only.

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

Access® Myoglobin Beckman Coulter Inc. Chaska, MN 55416 (K000196)

Related Devices

K231832 — Access Myoglobin · Beckman Coulter, Inc. · Sep 18, 2023
K080481 — ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS · Beckman Coulter, Inc. · Feb 20, 2009
K991277 — MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 · Diagnostic Products Corp. · Apr 27, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized oval shape on the left, with two curved lines running through it. To the right of the oval is the company name, "BECKMAN COULTER," written in a bold, sans-serif font. The overall design is simple and corporate, with a focus on clarity and readability. JUN 2 8 2002 # 510(k) SUMMARY 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 510(k) number is: : K021229 ### Submitter's Name and Address Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952)368-1611 Fax: (952)368-7610 Contact: Bruce Backlund Date Prepared: April 17, 2002 #### Device Names Myoglobin and Myoglobin Calibrators on the Access® Immunoassay Proprietary Name: Systems Common Name: Myoglobin Enzyme Immunoassay Classification Name: Myoglobin, Antigen, Antiserum, Control ### Predicate Device Access® Myoglobin Beckman Coulter Inc. Chaska, MN 55416 510(k) Number: K000196 #### Device Description The Myoglobin reagents. Myoglobin calibrators, the Access Access Immunoassay Analyzer and the Access 2 Immunoassay Analyzer comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma. ### Intended Use The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac Myoglobin levels in human serum and plasma using the Access Immunoassay Systems. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized oval shape on the left, with two curved lines running through it. To the right of the oval is the text "BECKMAN" in bold, uppercase letters, stacked above the word "COULTER", also in bold, uppercase letters. The logo is black and white. | Parameter | Access New Myoglobin | Access Current BCI Myoglobin | |------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For the quantitative determination of Myoglobin levels in human serum and plasma | For the quantitative determination of Myoglobin levels in human serum and plasma | | Assay Principles | A two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with mouse monoclonal anti-myoglobin- alkaline phosphatase conjugate, mouse monoclonal anti-myoglobin- biotin conjugate, and paramagnetic particles coated with goat anti-biotin. | A two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with mouse monoclonal anti-myoglobin-alkaline phosphatase conjugate, and paramagnetic particles coated with mouse monoclonal anti-myoglobin. | | Solid Support | Paramagnetic Particles | Paramagnetic Particles | | Detection System | Utilizes dioxetane-based chemiluminescent substrate; Measures light production from a chemiluminescent reaction | Utilizes dioxetane-based chemiluminescent substrate; Measures light production from a chemiluminescent reaction | | Calibrators | Liquid calibrators (frozen) prepared from buffered bovine serum albumin matrix with human cardiac Myoglobin at specified levels | Liquid calibrators prepared from buffered bovine protein matrix and human skeletal Myoglobin at specified levels | # Comparison of Technological Characteristics # Summary of Analytical Studies Precision: Within run imprecision ranged from 1.58%CV to 2.20%CV, betweenrun imprecision ranged from 2.34%CV to 4.24%CV and total imprecision ranged from 3.03%CV to 4.54%CV. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, abstract symbol on the left, resembling an oval shape with two curved lines running through it. To the right of the symbol is the company name, "BECKMAN COULTER," written in a bold, sans-serif font, with "BECKMAN" stacked above "COULTER." Analytical Sensitivity: The lowest detectable level of Myoglobin distinguishable from zero (Access Myoglobin calibrator S0) with 95% confidence is <1.0 ng/mL. Dilution Recovery (Linearity): Linearity studies performed by diluting lithium heparin plasma samples with Access Sample Diluent A provided an average recovery of the samples of 93%, with individual sample average recoveries ranging from 86% to 100%. Method Comparison: A comparison of cardiac Myoglobin values from 148 samples, ranging from 0.00 to 3.227.80 ng/mL, run with both the Access New Myoglobin assay and the Current BCI Myoglobin assay demonstrated good agreement with the following statistical data: Y =1.113X + 15.903 R=0.997 Matched Sample Comparison: No clinically significant bias was noted between lithium heparin plasma and sodium heparin plasma or serum samples. A bias was noted when using EDTA plasma samples. (Y= 0.8925X + 5.0115 R=0.9981)*. Analytical Specificity: There was no significant interference from therapeutic drugs or biological substances. None of the RF samples or the HAMA samples tested above the Upper Reference Limit (URL). Two heterophile samples tested above the URL. Of this group, both heterophile samples tested did not prove to be blocked by treatment with HBT (heterophile blocking tubes). Stability: Myoglobin reagents are stable for 56 days after opening and calibrators are stable for 60 days after opening. The calibration curve is stable for 56 days. Reference Intervals: Separate reference limits were computed for LHS (Lithium Heparin, Serum) and EDTA assays for males and females. The Lithium Heparin and Serum (LHS) upper reference limit (97.5th percentile) was determined to be 66 ng/mL for Females and the 106 ng/mL for Males. The EDTA upper reference limit (97.5" percentile) was determined to be 58 ng/mL for females and 91 ng/mL for males ### Conclusion Access Myoglobin and Myoglobin calibrators on the Access Immunoassay Systems are substantially equivalent to another test currently in commercial distribution for the measurement of Myoglobin. * See Reference Interval section Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084 {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 # JUN 2 8 2002 Re: k021229 Mr. Bruce Backlund Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084 Senior Regulatory Specialist Trade/Device Name: Myoglobin 100 and Myoglobin Calibrators on the Access® Immunoassay System Regulation Number: 21 CFR 866.5680; 21 CFR 862.1150 Regulation Name: Myoglobin immunological test system; Calibrator Regulatory Class: Class II Product Code: DDR; JIS Dated: April 17, 2002 Received: April 18, 2002 Dear Mr. Backlund: 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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mav 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ #### 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmaldsmamain.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 {5}------------------------------------------------ INDICATIONS FOR USE STATEMENT Page 510(k) Number (if known): KO21229 Device Name: Myoglobin™ and Myoglobin Calibrators on the Access® Immunoassay System #### Indications For Use: Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease. Gran Coops (Division Sign-Off) Division of Clinical Laboratory Devices Division of Clinical Laboratory Devices 510(k) Number K021229 (Please do not write Below This Line-continue on another PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Counter Use (Per 21 CFR 801.109) OR Over-The (Optional Format 1-2-96)