VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303

Q: Who is the manufacturer of VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303?

Ortho-Clinical Diagnostics filed the 510(k) submission for VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 (K062838).

Q: What is the FDA product code for VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303?

MMI. 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 VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303?

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

Q: What are the predicate devices for VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303?

BECKMAN Access® AccuTnI Troponin I assay (K974075); VITROS Troponin I Range Verifiers (K992349).

Q: Who can help prepare an FDA 510(k) submission like VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303?

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.

K062838 · Ortho-Clinical Diagnostics · MMI · Dec 19, 2006 · Clinical Chemistry

Device Facts

Record ID	K062838
Device Name	VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
Applicant	Ortho-Clinical Diagnostics
Product Code	MMI · Clinical Chemistry
Decision Date	Dec 19, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1215
Device Class	Class 2

Intended Use

VITROS® Troponin I ES Reagent Pack: For in vitro diagnostic use only. For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification. Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures. VITROS® Troponin I ES Calibrators: For in vitro diagnostic use only. For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA). VITROS® Troponin I ES Range Verifiers: For in vitro diagnostic use only. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI).

Device Story

VITROS Troponin I ES assay is an in vitro diagnostic test for quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma. The device utilizes the VITROS Immunodiagnostic System, an automated instrumentation platform. The assay employs a chemiluminescence immunoassay principle with enzyme-labeled mouse monoclonal antibodies. The system processes patient samples (80µL) to provide cTnI concentration values. Healthcare providers use these results to assess myocardial damage, diagnose acute myocardial infarction, and perform risk stratification for patients with non-ST-segment elevation acute coronary syndromes. The device is intended for clinical laboratory use.

Clinical Evidence

Bench testing only. Performance characteristics compared to predicate include: analytical sensitivity (<0.009 ng/mL), measuring range (0.012-80.0 ng/mL), and AMI cut-off (0.120 ng/mL). Sensitivity and specificity over 0-24 hours were evaluated (Sensitivity 69-90%, Specificity 94-96%).

Technological Characteristics

Chemiluminescence immunoassay; enzyme-labeled mouse monoclonal antibodies; automated instrumentation; liquid format reagents/calibrators; human serum-based matrix for verifiers. Complies with CLSI standards C24, EP5, EP6, EP7, EP9, EP17, C28, GP10, H3, H4, M29.

Indications for Use

Indicated for quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) to aid in assessment of myocardial damage, diagnosis of acute myocardial infarction, and risk stratification of patients with non-ST-segment elevation acute coronary syndromes.

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

BECKMAN Access® AccuTnI Troponin I assay (K974075)
VITROS Troponin I Range Verifiers (K992349)

Related Devices

K972094 — TARGET CARDIAC TROPONIN I TEST · Texas Immunology, Inc. · Jul 23, 1997
K980528 — CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) · Chiron Diagnostics Corp. · Mar 3, 1998
K031031 — VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS · Ortho-Clinical Diagnostics, Inc. · Sep 29, 2003
K991795 — IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 · Diagnostic Products Corp. · Jun 9, 1999
K993309 — BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY · Bayer Corp. · Dec 6, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ ## 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. Ko 62838 The assigned 510(k) number is ### Submitter Name, Address, Contact 1. Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-3730 Contact Person: Charlotte Baker ### Preparation Date 2. Date 510(k) prepared: September 20, 2006 ### 3. Device Name Trade or Proprietary Names: VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack VITROS® Immunodiagnostic Products Troponin I ES Calibrators VITROS® Immunodiagnostic Products Troponin I ES Range Verifiers Common Name: Troponin I assay and controls Classification Names: Immunoassay Method, Troponin Subunit, (862.1215), Class II Calibrator, multi-analyte mixture, (862.1150), Class II Quality control material, (assayed and unassayed), (862.1660), Class I {1}------------------------------------------------ #### Predicate Device 4. The VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack and Calibrators (the VITROS Troponin I ES assay) are substantially equivalent to the BECKMAN Access® AccuTnI Troponin I assay (K974075). The VITROS® Immunodiagnostic Products Troponin I ES Range Verifiers are substantially equivalent to the VITROS Troponin I Range Verifiers (K992349). ### ક. Device Description - 1. The VITROS Immunodiagnostic Products range of immunoassav products: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, the VITROS Immunodiagnostic Products Troponin I ES Calibrators and the VITROS Immunodiagnostic Products Troponin I ES Range Verifiers, (which are combined by the VITROS Immunodiagnostic System to perform the VITROS Troponin I ES assay), and VITROS Immunodiagnostic Products High Sample Diluent B. - 2. The VITROS Immunodiagnostic System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). - 3. Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310). Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894). The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products. ### Ortho-Clinical Diagnostics, Inc. {2}------------------------------------------------ #### Device Intended Use 6. ### VITROS Troponin I ES Reagent Pack: For in vitro diagnostic use only. For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification. Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures. ### VITROS Troponin I ES Calibrators: For in vitro diagnostic use only. For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA). ### VITROS Troponin I ES Range Verifiers: For in vitro diagnostic use only. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI). #### 7. Comparison to Predicate Device The VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack and Calibrators are substantially equivalent to the BECKMAN Access® AccuTnI Troponin I Reagent Pack and Calibrators (K974075). The VITROS® Immunodiagnostic Products Troponin I ES Range Verifiers are substantially equivalent to the VITROS Troponin I Range Verifiers (K992349). Table 1 (page 4) presents the similarities and differences of both assays. Table 2 (page 5) presents the similarities and differences of both calibrators Table 3 (page 5) presents the similarities and differences of both range verifiers. {3}------------------------------------------------ | Similarities | | | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Characteristic | New Device-VITROS® Troponin I ES assay | Predicate Device-BECKMAN Access® AccuTnI Troponin I assay | | Intended Use | For the in vitro quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification. | For the in vitro quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. | | | Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non- ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures. | Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures. | | Basic Principal | Chemiluminescence Immunoassay | Chemiluminescence Immunoassay | | Tracer | Enzyme labeled | Enzyme labeled | | Instrumentation | Automated Immunoassay System | Automated Immunoassay System | | Antibody | Mouse monoclonal | Mouse monoclonal | | Sample type | Serum and plasma (heparin and EDTA) | Serum and plasma (EDTA and heparin) | | Organizations used/referenced | NACB, ESC/ACC/AHA, WHO | NACB, ESC/ACC/AHA, WHO | | Lower Limit of Detection | 0.012ng/mL | Not applicable | | Differences | | | | Basic principle | Solid phase immunoassay | 2-site immunoenzymatic assay | | Sample volume | 80µL | 40µL | | Measuring range | 0.012-80.0 ng/mL | 0.01-100 ng/mL | | Analytical Sensitivity | <0.009 ng/mL | 0.01 ng/mL | | Hook Effect | None up to 14,000 ng/mL | None up to 1,920 ng/mL | | Expected Values: 99th percentile URL | 0.034 ng/mL | 0.04 ng/mL | | AMI Cut off | 0.120 ng/mL (95% sens., 93% spec.) | 0.50 ng/mL (96% sens., 94% spec.) | | 10% CV | 0.034 ng/mL | 0.06 ng/mL | | Spec.& Sens over time (0 to 24 hrs.) | Sens. Range 69-90% Spec. Range 94-96% | Sens. Range 46-91% Spec. Range 96-88% | | CLSI Standards Used or Referenced | C24, EP5, EP6, EP7, EP9, EP17, C28, GP10, H3, H4, M29 | EP6-P, EP5-A, EP7-P | Comparison of the VITROS and BECKMAN Troponin I assays Table 1 {4}------------------------------------------------ ### Table 2 Comparison of the VITROS and BECKMAN Troponin I Calibrators | Similarities | | | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Characteristic | New Device-VITROS® Troponin I ES Calibrators | Predicate Device-BECKMAN Access® AccuTnI Troponin I Calibrators | | Intended Use | For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA). | Intended to calibrate the Access AccuTnI assay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. | | Calibrator Format | Liquid | Liquid | | Differences | | | | Calibrator Levels | 3 | 6 | | Table 3 Comparison of the VITROS Troponin I Range Verifiers | | | | |-------------------------------------------------------------|--|--|--| | | | | | | | Similarities | | | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Device Characteristic | New Device-VITROS® Troponin I ES Range Verifiers | Predicate Device-VITROS® Troponin I Range Verifiers | | | Intended Use | For in vitro us in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of cardiac Troponin I (cTnI). | For in vitro us in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of cardiac Troponin I (cTnI). | | | Matrix of Range Verifiers | Human serum based matrix with antimicrobial agent | Human serum based matrix with bovine proteins and antimicrobial agent | | | Differences | | | | | Range Verifier Levels | Low and High (0 & 80 ng/mL) | Low and High (0 & 95 ng/mL) | | | Format | Liquid | Freeze-dried | | ### 8. Conclusions The data presented provide a reasonable assurance that the VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, Calibrators and Range Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the predicate devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with outstretched wings, stylized with three thick, curved lines representing the wings and body. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Charlotte Baker Regulatory Affairs Specialist Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. Rochester, NY 14626-5101 DEC 1 9 2006 Re: k062838 > Trade/Device Name: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack VITROS Immunodiagnostic Products Troponin I ES Calibrator VITROS Immunodiagnostic Products Troponin I ES Range Verifier Regulation Number: 21 CFR§ 862.1215 21 CFR§ 862.1150 21 CFR8 862.1660 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JIT, JJX Dated: September 21, 2006 Received: September 26, 2006 Dear Ms. Baker: 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 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). {6}------------------------------------------------ ## 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 (240) 276-0484. 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/industry/support/index.html. Sincerely yours. Alberto Gutierrez Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Statement of Intended Use | 510(k) Number (if known): | < 0 6 2838 | | | |------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Device Names: | VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack VITROS® Immunodiagnostic Products Troponin I ES Calibrators VITROS® Immunodiagnostic Products Troponin I ES Range Verifiers | | | | Indications for Use: | VITROS® Troponin I ES Reagent Pack: For in vitro diagnostic use only. For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification. | | | | | Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures. | | | | | VITROS® Troponin I ES Calibrators: For in vitro diagnostic use only. For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA). | | | | | VITROS® Troponin I ES Range Verifiers: For in vitro diagnostic use only. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI). | | | | 1 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) | | | | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | | | | | Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OMD) | | | | | ign- | | | Ortho-Clinical Diagnostics, Inc. Office of In Vitro Diagnostic Device Evaluation and Safety September 20 , 2006