(85 days)
No
The description focuses on standard immunoassay technology and instrumentation, with no mention of AI or ML.
No
The device is described as an "in vitro quantitative measurement" and is used to aid in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" states that the device is for "quantitative measurement of Troponin I (cTnI) in human serum or plasma... to aid in the diagnosis of myocardial infarction." The term "diagnosis" clearly indicates its use as a diagnostic device.
No
The device description explicitly details hardware components (VITROS Immunodiagnostic System - instrumentation) and physical reagents, indicating it is not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the in vitro quantitative measurement of Troponin I (cTnI) in human serum or plasma... to aid in the diagnosis of myocardial infarction." The phrase "in vitro" is a key indicator of an IVD, meaning it's used outside of the living body. The purpose of measuring an analyte in a body fluid for diagnostic purposes is the core function of an IVD.
- Device Description: The description details a system that uses immunoassay products (reagents and calibrators) to measure analytes in human body fluids. This process of analyzing biological samples to obtain diagnostic information is characteristic of IVDs.
- Predicate Device: The predicate device listed is the "DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method," which is also an IVD for measuring Troponin I. This further supports the classification of the described device as an IVD.
The entire description points to a system designed to perform laboratory tests on human samples to provide information for medical diagnosis.
N/A
Intended Use / Indications for Use
For the in vitro quantitative measurement of Troponin I (cTnI) in human serum or plasma (EDTA or heparin), to aid in the diagnosis of myocardial infarction.
For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (EDTA or heparin).
Product codes (comma separated list FDA assigned to the subject device)
MMI
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: 1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Troponin I Reagent Pack, VITROS Immunodiagnostic Products Troponin I Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the ... VITROS Troponin I 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). 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)
Comparison to predicate device:
The VITROS Immunodiagnostic Products Troponin I Reagent Pack and VITROS Immunodiagnostic Products Troponin I Calibrators are substantially equivalent to the DADE Dimension RxL Cardiac Troponin-I (TROP) Method which was cleared by the FDA (K973650) for IVD use.
The relationship between the VITROS Troponin I assay and the DADE Dimension RxL Cardiac Troponin-I assay, determined by Passing and Bablok Regression, is: VITROS Troponin I assay = 1.05 x X - 0.151 (ng/mL), with a Spearman rank correlation coefficient of 0.983, where X is DADE Dimension RxL Cardiac Troponin-I assay. This relationship was determined from a panel of patient samples from a variety of clinical categories.
In addition to the above mentioned correlation study, studies were performed to determine the precision, analytical sensitivity, specificity and expected values of the VITROS Troponin I assay, (refer to the VITROS Troponin I Reagent Pack package insert for summaries of the results of these studies).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Spearman rank correlation coefficient of 0.983.
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
Chapter 1 - 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: 1993300.
1: - Submitter --------------------------------------------------------------------------------------------------------------------------------------------------------------name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 contact (716) 453-4041
Contact Person: Marlene Shulman
- Date 510(k) prepared: 14th July 1999 2. Preparation date
- Trade or Proprietary Name: 3. Device VITROS Immunodiagnostic Products Troponin I Reagent Pack name VITROS Immunodiagnostic Products Troponin I Calibrators
Common Name : TROPONIN I assay Classification Name: Immunoassay Method, Troponin Subunit
The VITROS Immunodiagnostic Products Troponin I Reagent Pack and 4. Predicate device VITROS Immunodiagnostic Products Troponin I Calibrators are substantially equivalent to the DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method.
Continued on next page
1
510(k) Summary. Continued
·
- The VITROS Immunodiagnostic System uses luminescence as the signal in 5. Device 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 Troponin I Reagent Pack, VITROS Immunodiagnostic Products Troponin I Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the ... VITROS Troponin I 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)
Continued on next page
premarket notification (K964310).
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 immunoassav
products. | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 6. | Device
intended
use | The VITROS Troponin I assay is intended for the in vitro quantitative
measurement of Troponin I (cTnI) in human serum or plasma (EDTA or
heparin), to aid in the diagnosis of myocardial infarction. | |
| 7. | Comparison
to predicate
device | The VITROS Immunodiagnostic Products Troponin I Reagent Pack and
VITROS Immunodiagnostic Products Troponin I Calibrators are
substantially equivalent to the DADE Dimension RxL Cardiac Troponin-I
(TROP) Method which was cleared by the FDA (K973650) for IVD use. | |
| | | The relationship between the VITROS Troponin I assay and the DADE
Dimension RxL Cardiac Troponin-I assay, determined by Passing and
Bablok Regression, is: | |
| | | VITROS Troponin I assay = 1.05 x X - 0.151 (ng/mL),
with a Spearman rank correlation coefficient of 0.983,
where X is DADE Dimension RxL Cardiac Troponin-I assay. | |
| | | This relationship was determined from a panel of patient samples from a
variety of clinical categories. | |
| | | In addition to the above mentioned correlation study, studies were performed
to determine the precision, analytical sensitivity, specificity and expected
values of the VITROS Troponin I assay, (refer to the VITROS Troponin I
Reagent Pack package insert for summaries of the results of these studies). | |
| | | Table 1 lists the characteristics of the assays performed using the VITROS
Troponin I assay and the DADE Dimension RxL Cardiac Troponin-I Assay. | |
| Device | VITROS Troponin I | DADE Dimension RxL | |
| Characteristic | assay | Cardiac Troponin-I | |
| Calibration range | 0-100 ng/mL | 0-50 ng/mL | |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay | |
| Tracer | Enzyme labeled | Enzyme labeled | |
| Antibody | Mouse monoclonal anti-
Troponin I antibody
(Biotinylated antibody
reagent).
Goat polyclonal anti-
Troponin I antibody
(HRP-Conjugate reagent). | Mouse monoclonal anti-
Troponin I antibody (in
Antibody Tablets and
Conjugate). | |
| Instrumentation | VITROS
Immunodiagnostic
System | DADE Dimension RxL
clinical chemistry system | |
| Sample type | Serum and plasma
(EDTA or heparin). | Serum and plasma
(heparin). | |
| Sample volume | 50μL | 60μL | |
| Incubation time and
temperature | 8 minutes at 37°C | 5.4 minutes at 37°C | |
..............................................................................................................................................................................
Continued on next page
3
510(k) Summary, Continued
の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時
-
- Comparison Table 1 to predicate device, Continued
.
- Comparison Table 1 to predicate device, Continued
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
.
Continued on next page
4
510(k) Summary, Continued
The data presented in the pre-market notification demonstrate that the 8. Conclusions performance of the VITROS Troponin I assay 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 Troponin I assay 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 image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 8 1999
Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, New York 14626-5101
Re: K992366
· Trade Name: VITROS Immunodiagnostic Products Froponin I Reagent Packs VITROS Immunodiagnostic Products Troponin I Calibrators Regulatory Class: II Product Code: MMI Dated: September 22, 1999 Received: September 23, 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 reguirements 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 (QS) 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 1 of 1
510(k) Number (if known):
Device Name:
VITROS Immunodiagnostic Products Troponin I Reagent Pack
VITROS Immunodiagnostic Products Troponin I Calibrators
Indications for_Use:
For the in vitro quantitative measurement of Troponin I (cTnI) in human serum or plasma (EDTA or heparin), to aid in the diagnosis of myocardial infarction.
For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (EDTA or heparin).
Jan Cooper
(Division Sign-Off) (Division of Clinical Laboratory Devices 2 9 9236 510(k) Number -
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Troponin I Reagent Pack
6
VITROS Immunodiagnostic Products Troponin I Calibrators