(21 days)
No
The document describes a standard immunoassay system for measuring CK-MB levels, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) system used to measure enzymes in bodily fluids for diagnosis, not to treat a disease or condition.
Yes
The Intended Use section explicitly states that the device is "intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum and plasma in the diagnosis and treatment of myocardial infarction." This indicates its use for diagnostic purposes.
No
The device description clearly outlines a system comprised of reagent packs, calibrators, and instrumentation, indicating a hardware component is essential to its function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum and plasma in the diagnosis and treatment of myocardial infarction." This involves testing samples taken from the human body (serum and plasma) in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a system that uses "luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma." This further confirms that it's designed for testing biological samples.
- Calibrators: The VITROS CK-MB Calibrators are described as being "For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum and plasma." Calibrators are a common component of IVD systems used to ensure accurate measurements of analytes in biological samples.
The combination of testing human body fluids in vitro for diagnostic purposes clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JHX, JIS
Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in 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:
- 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).
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
- Common reagents used by the VITROS System in each assay.
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
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.(b)
Classification. Class II.
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
-
- Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 contact (716) 453-4041
Marlene Shulman Contact Person:
- Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 contact (716) 453-4041
-
Date Special 510(k) prepared: 10 September 1999 2. Preparation date
-
- 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
-
- 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
- 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.
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:
-
- 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).
-
- 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).
-
- 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
-
- 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
- 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