VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS

Q: Who is the manufacturer of VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS?

Ortho-Clinical Diagnostics filed the 510(k) submission for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS (K993068).

Q: What is the FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS?

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 VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS?

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

Q: Who can help prepare an FDA 510(k) submission like VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS?

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.

K993068 · Ortho-Clinical Diagnostics · JHX · Oct 4, 1999 · Clinical Chemistry

Device Facts

Record ID	K993068
Device Name	VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
Applicant	Ortho-Clinical Diagnostics
Product Code	JHX · Clinical Chemistry
Decision Date	Oct 4, 1999
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1215
Device Class	Class 2

Intended Use

VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum and plasma in the diagnosis and treatment of myocardial infarction. VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum and plasma.

Device Story

VITROS CK-MB assay performs quantitative measurement of CK-MB in human serum or plasma; utilizes VITROS Immunodiagnostic System instrumentation. Input: patient serum/plasma sample (40μL). Principle: solid phase immunoassay using coated microwells; enzyme-labeled tracer; mouse monoclonal anti-CK-BB (biotinylated) and anti-CK-MB (HRP-conjugate) antibodies. Process: 16-minute incubation at 37°C with shaking; luminescence signal detection. Output: quantitative CK-MB concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and managing myocardial infarction.

Clinical Evidence

Bench testing only. Performance demonstrated using commercially available reagents and patient samples across various clinical categories to validate the use of serum and plasma (EDTA or heparin). No clinical prospective or retrospective studies were required for this 510(k) submission.

Technological Characteristics

Solid phase immunoassay; luminescence-based detection. Reagents: mouse monoclonal anti-CK-BB (biotinylated) and anti-CK-MB (HRP-conjugate). Instrumentation: VITROS Immunodiagnostic System. Sample volume: 40μL. Incubation: 16 minutes at 37°C. Calibration range: 0-400 ng/mL. System utilizes coated microwells for separation.

Indications for Use

Indicated for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin) 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

VITROS Immunodiagnostic Products CK-MB Reagent Pack (K973030)

Reference Devices

VITROS Immunodiagnostic Products Total B-hCG Reagent Pack (K970894)
VITROS Immunodiagnostic System (K962919)
VITROS Immunodiagnostic Products Total T3 Reagent Pack (K964310)

Related Devices

K962126 — ACS CKMB II IMMUNOASSAY · Ciba Corning Diagnostics Corp. · Jun 21, 1996
K102706 — CKMB UDR ASSAY · SENTINEL CH. SpA · Aug 19, 2011
K962549 — VIDAS CREATINE KINASE MB ASSAY 30-421 · Biomerieux Vitek, Inc. · Aug 30, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ ## Summary Information # 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: K 993.068 - 1. Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 contact (716) 453-4041 Marlene Shulman Contact Person: - Date Special 510(k) prepared: 10 September 1999 2. Preparation date - 3. Device Trade or Proprietary Name: name VITROS Immunodiagnostic Products CK-MB Reagent Pack VITROS Immunodiagnostic Products CK-MB Calibrators : CK-MB assay Common Name Classification Name: Creatine phosphokinase/ creatine kinase or isoenzymes test system - 4. Predicate The VITROS Immunodiagnostic Products CK-MB Reagent Pack for use with device human serum and plasma (EDTA or heparin) and VITROS Immunodiagnostic Products CK-MB Calibrators are substantially equivalent to the VITROS Immunodiagnostic Products CK-MB Reagent Pack for use with human serum and VITROS Immunodiagnostic Products CK-MB Calibrators. Continued on next page {1}------------------------------------------------ ## 510(k) Summary. Continued #### 5. Device The VITROS Immunodiagnostic System uses luminescence as the signal in description the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: - 1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products CK-MB Reagent Pack, VITROS Immunodiagnostic Products CK-MB Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS CK-MB assay, and VITROS Immunodiagnostic Products High Sample Diluent B). Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total B-hCG Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG Calibrators 510(k) premarket notification (K970894). - 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). Continued on next page {2}------------------------------------------------ # 510(k) Summary, Continued • | 5. | Device description, Continued | The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products. | |----|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 6. | Device intended use | The VITROS CK-MB assay is intended for the in vitro quantitative measurement of CK-MB in human serum or plasma (EDTA or heparin). | | 7. | Comparison to predicate device | The VITROS Immunodiagnostic Products CK-MB Reagent Pack for use with human serum and plasma (EDTA or heparin) and VITROS Immunodiagnostic Products CK-MB Calibrators are substantially equivalent to VITROS Immunodiagnostic Products CK-MB Reagent Pack for use with human serum which was cleared by the FDA (K973030) for IVD use. Table 1 lists the characteristics of the assays performed using the VITROS CK-MB assay for use with human serum and plasma (EDTA or heparin) and the VITROS CK-MB assay for use with human serum. | Continued on next page . . {3}------------------------------------------------ # 510(k) Summary, Continued - 7. Comparison Table 1 to predicate device, Continued | Device Characteristic | VITROS CK-MB assay for use with human serum and plasma (EDTA or heparin) | VITROS CK-MB assay for use with human serum | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Calibration range | 0-400 ng/mL | 0-400 ng/mL | | Basic principle | Solid phase immunoassay | Solid phase immunoassay | | Tracer | Enzyme labeled | Enzyme labeled | | Antibody | Mouse monoclonal anti- CK-BB antibody (Biotinylated antibody reagent). Mouse monoclonal anti- CK-MB antibody (HRP- Conjugate reagent). | Mouse monoclonal anti- CK-BB antibody (Biotinylated antibody reagent). Mouse monoclonal anti- CK-MB antibody (HRP- Conjugate reagent) | | Instrumentation | VITROS Immunodiagnostic System | VITROS Immunodiagnostic System | | Sample type | Serum and plasma (EDTA or heparin). | Serum | | Sample volume | 40μL | 40μL | | Incubation time and temperature | 16 minutes at 37°C with shaking | 16 minutes at 37°C with shaking | Continued on next page {4}------------------------------------------------ #### 510(k) Summary, Continued 8. Conclusions The data presented in the pre-market notification demonstrate that the performance of the VITROS CK-MB assay for use with human serum and plasma (EDTA or heparin) is substantially equivalent to the cleared predicate device. > Equivalence was demonstrated using currently commercially available reagents along with patient samples covering a variety of clinical categories. The data presented in the premarket notification provide a reasonable assurance that the VITROS CK-MB assay for use with human serum and plasma (EDTA or heparin) is safe and effective for the stated intended use. {5}------------------------------------------------ Image /page/5/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" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by three curved lines that suggest a head, torso, and legs. OCT 4 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, New York 14626-5101 K993068 Re: > Trade Name: VITROS Immunodiagnostic Products CK-MB Reagent Pack VITROS Immunodiagnostic Products CK-MB Calibrators Regulatory Class: II Product Code: JHX, JIS Dated: September 10, 1999 Received: September 13, 1999 Dear Ms. Shulman: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {6}------------------------------------------------ #### Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Statement of Intended Use Page I of 1 | 510(k) Number (if known): | K 993068 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | VITROS Immunodiagnostic Products CK-MB Reagent Pack VITROS Immunodiagnostic Products CK-MB Calibrators | | Indications for Use: | VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum and plasma in the diagnosis and treatment of myocardial infarction. | | | VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum and plasma. | Jean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K993068 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96) Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products CK-MB Reagent Pack -VITROS Immunodiagnostic Products CK-MB Calibrators