Who can help prepare an FDA 510(k) submission like CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372?

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.

CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372

Q: Who is the manufacturer of CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372?

Beckman Coulter, Inc. filed the 510(k) submission for CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 (K030012).

Q: What is the FDA product code for CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372?

JHX. It is classified under 21 CFR 862.1215 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372?

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

K030012 · Beckman Coulter, Inc. · JHX · Jan 17, 2003 · Clinical Chemistry

Device Facts

Record ID	K030012
Device Name	CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
Applicant	Beckman Coulter, Inc.
Product Code	JHX · Clinical Chemistry
Decision Date	Jan 17, 2003
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1215
Device Class	Class 2

Intended Use

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

Device Story

Device is a paramagnetic particle, chemiluminescent immunoassay for quantitative CK-MB measurement in human serum and plasma. Operates on Access Immunoassay Systems (Access, Access 2, Synchron LXi 725). Principle: two-site 'sandwich' immunoassay using monoclonal antibodies conjugated with alkaline phosphatase; dioxetane-based chemiluminescent substrate produces light proportional to CK-MB concentration. Used in clinical laboratory settings by trained personnel. Output is a quantitative CK-MB value used by clinicians to diagnose and monitor myocardial infarction.

Clinical Evidence

Bench testing only. Analytical studies included: imprecision (total CV 2.66%–3.54%), analytical sensitivity (<0.1 ng/mL), and linearity (average recovery 102%). Method comparison against the predicate (n=120 samples, range 0.6–208.7 ng/mL) showed high correlation (r=0.997, y=0.879x+0.907). Analytical specificity confirmed no significant cross-reactivity with CK-BB or CK-MM isoenzymes or interference from common substances.

Technological Characteristics

Paramagnetic particle solid support; two-site 'sandwich' immunoassay; alkaline phosphatase enzyme conjugate; dioxetane-based chemiluminescent detection system. Liquid calibrators in buffered bovine serum albumin matrix. System is an automated immunoassay analyzer.

Indications for Use

Indicated for the quantitative determination of CK-MB levels in human serum and plasma to aid in the diagnosis and treatment of myocardial infarction.

Regulatory Classification

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.

Predicate Devices

Access® CK-MB Assay for Use on the Access® Immunoassay Analyzer (K000716)

Related Devices

K994439 — ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 · Beckman Coulter, Inc. · Jan 14, 2000
K234005 — Access CK-MB · Beckman Coulter, Inc. · Feb 16, 2024
K962126 — ACS CKMB II IMMUNOASSAY · Ciba Corning Diagnostics Corp. · Jun 21, 1996
K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY · Roche Diagnostics · Oct 18, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, resembling a stylized eye. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked on top of each other in a bold, sans-serif font. JAN 1 7 2003 ## 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: K030012 ### Submitter's Name and Address Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952)368-1323 Fax: (952)368-7610 Contact: Brent Taber Date Prepared: December 31, 2002 ### Device Names | Proprietary Name: | CK-MB and CK-MB Calibrators on the Access® Immunoassay Systems | |-------------------|-------------------------------------------------------------------| |-------------------|-------------------------------------------------------------------| - Common Name: CK-MB Enzyme Immunoassay Classification Name: Fluorometric Method, CPK or Isoenzymes ### Predicate Device Access® CK-MB Assay for Use on the Access® Immunoassay Analyzer Beckman Coulter, Inc. Chaska, MN 55318 510(k) Number: K000716 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black 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 modern. # Device Description The Access CK-MB reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, and Synchron LXi 725) comprise the Access Immunoassay Systems for the quantitative determination of CK-MB in human serum and plasma. # Intended Use The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems. | Attribute | Current Access CK-MB | Modified Access CK-MB | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For the measurement of CK-MB in human serum and plasma | For the measurement of CK-MB in human serum and plasma | | Assay Principles | Utilizes the binding of CK-MB to specific monoclonal antibodies in a two site "sandwich" immunoassay; Utilizes alkaline phosphatase enzyme conjugated to monoclonal antibody | Utilizes the binding of CK-MB to specific monoclonal antibodies in a two site "sandwich" immunoassay; Utilizes alkaline phosphatase enzyme conjugated to monoclonal antibody | | 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 prepared from buffered bovine serum albumin matrix with recombinant CK-MB at specified levels | Liquid calibrators prepared from buffered bovine serum albumin matrix with recombinant CK-MB at specified levels | # Comparison of Technological Characteristics {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black oval shape on the left, with two curved white lines running through it. To the right of the oval is the company name, "BECKMAN COULTER," written in a bold, sans-serif font. The text is stacked, with "BECKMAN" on top of "COULTER." ## Summary of Analytical Studies Within run imprecision ranged from 1.15%CV to 2.32%CV, Precision: between-run imprecision ranged from 1.47%CV to 2.89%CV and total imprecision ranged from 2.66%CV to 3.54%CV at levels ranging between 4.5 and 172.3 ng/mL. Analytical Sensitivity: The lowest detectable level of CK-MB distinguishable from zero (Access CK-MB calibrator S0) with 95% confidence is <0.1 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 102%, with individual sample average recoveries ranging from 95% to 109%. Method Comparison: A comparison of CK-MB values from 120 samples, ranging from 0.6 to 208.7 ng/mL (modified CK-MB), run with both the modified Access CK-MB assay and the current CK-MB assay demonstrated good agreement with the following statistical data: y = 0.879x + 0.907, r = 0.997. Analytical Specificity: There was no significant interference from therapeutic drugs, biological substances, or heterophile samples. There was no significant cross-reactivity with other creatine kinase isoenzymes (CK-BB or CK-MM). Stability: CK-MB 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 intervals were calculated for lithium heparin plasma and serum, and EDTA plasma. The lithium heparin plasma and serum reference interval (95% central fraction) is 0.6 - 6.3 ng/mL. The EDTA plasma reference interval (95% central fraction) is 0.5 - 5.0 ng/mL. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black circle with two curved white lines inside. The text "BECKMAN COULTER" is in bold, sans-serif font. # Conclusion CK-MB and CK-MB Calibrators on the Access Immunoassay Systems is substantially equivalent to Access® CK-MB Assay for Use on the Access® Immunoassay Analyzer for the measurement of CK-MB in human serum and plasma. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure, composed of three curved lines. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JAN 1 7 2003 Mr. Brent Taber Senior Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Chaska, MN 55318-1084 k030012 Re: > Trade/Device Name: CK-MB and CK-MB Calibrators on the Access Immunoassay Systems Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system. Regulatory Class: Class II Product Code: JHX, JIS Dated: December 31, 2002 Received: January 2, 2003 Dear Mr. Taber: 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 (OS) regulation (21 CFR Part 820). {5}------------------------------------------------ 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). 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/cdrh/dsma/dsmamain.html. Sincerely yours, Steven Putman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # INDICATIONS FOR USE STATEMENT Page / of / 510(k) Number (if known): K030012 Device Name: CK-MB and CK-MB Calibrators on the Access® Immunoassay Systems #### Indications For Use: The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction. Han Coogen (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number. K030012 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) X OR Over-The Counter Use (Optional Format 1-2-96)