(28 days)
The MYO TestPak used on the Stratus® CS STAT Fluorometric Analyzer is an in vitro diagnostic product for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin are used as aids in the rapid diagnosis of renal and heart disease, e.g. acute myocardial infarction.
The MYO TestPak consists of a plastic cartridge with five wells and a small square of glass fiber paper embedded in it. The method utilizes a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the MYQ TestPak. Sample is then added onto the paper where it reacts with the immobilized anti-myoglobin antibody. After a short incubation, a conjugate consisting of enzyme-labeled antibody directed against a distinct antigenic site on the myoglobin molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzymelabeled antibody reacts with the bound myoglobin, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone of the TestPak. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of myoglobin in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
The provided text focuses on the premarket notification (510(k)) for a medical device called the "Stratus® CS Myoglobin (MYO) TestPak." The key purpose of this submission is to demonstrate substantial equivalence to a previously cleared device, specifically concerning a change in the recommended frequency of quality control (QC) testing from daily to weekly.
Here's an analysis based on your requested information, highlighting what is available and what is not in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative sense for overall device performance. Instead, the core "acceptance criteria" for this specific submission is that the change in QC frequency does not adversely affect the performance of the device, and that the device remains substantially equivalent to its predicate.
The reported device performance, in the context of this submission, is qualitative: "The QC data collected supports the recommended change in QC frequency and indicates the change will not adversely affect performance of the device." No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision) from a new study are provided, as the submission relies on the established performance of the predicate device and the new QC data's non-inferiority.
| Acceptance Criteria (Implicit for the QC frequency change) | Reported Device Performance (Regarding QC frequency change) |
|---|---|
| The change in recommended QC frequency (from daily to weekly) does not adversely affect the performance of the device. | "The QC data collected supports the recommended change in QC frequency and indicates the change will not adversely affect performance of the device." |
| The device remains substantially equivalent to the predicate device despite the change in QC frequency. | Conclusion states, "Both assays are in vitro immunoassays with intended uses for the measurement of Myoglobin in heparinized plasma. The modified device differs from the device cleared under K981102 only in the recommended QC frequency in product labeling." and "Comments on Substantial Equivalence: ... The QC data collected supports the recommended change in QC frequency and indicates the change will not adversely affect performance of the device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the QC data that supported the change in frequency, nor does it detail the provenance of this data (e.g., country of origin, retrospective or prospective). It simply refers to "The QC data collected."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is an in vitro diagnostic (IVD) for measuring myoglobin, which is a quantitative biochemical measurement. The "ground truth" for the performance of such a device is typically established through reference methods, certified calibrators, and statistical analysis of assay performance (e.g., precision, linearity, accuracy against known standards), rather than expert consensus on images or clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described in point 3, this is an IVD for quantitative measurement. Adjudication methods like 2+1 or 3+1 are typical for subjective interpretations (e.g., image reading) where multiple experts resolve disagreements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device, nor is it a device that involves human readers interpreting results in a way that an MRMC study would be relevant. It's an automated IVD system providing a quantitative biochemical result.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an automated in vitro diagnostic device, so its primary operation is "standalone" in terms of performing the assay and generating a quantitative result. The submission is not about an algorithm, but rather a chemical assay system. No specific study details of a standalone performance evaluation (beyond the predicate device's established performance) are provided, as the submission focuses on the implications of changing QC frequency.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an in vitro diagnostic device measuring a biomarker (myoglobin), the "ground truth" for its analytical performance is typically established by:
- Reference methods: Comparing results to a gold standard analytical method.
- Certified reference materials/calibrators: Samples with precisely known concentrations of myoglobin.
- Split sample comparisons: Testing samples against a legally marketed, validated device.
The document does not detail specific "ground truth" types used for the original validation of the predicate device, nor for the QC data supporting the frequency change, but these would be the standard approaches for such a device.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI models that require a "training set." It is a chemical assay system.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Dade Behring
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
Summary of Safety and Effectiveness Information
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.
| Submitter's Name: | Rebecca S. AyashDade Behring Inc.Building 500, Mailbox 514P.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Date of Preparation: | 11/6/98 |
| Device Name: | Stratus® CS Myoglobin (MYO) TestPak |
| Classification Name: | Myoglobin Immunological Test System |
| Predicate Device: | Stratus® CS Myoglobin (MYO) TestPak (K981102) |
Device Description: The MYO TestPak consists of a plastic cartridge with five wells and a small square of glass fiber paper embedded in it. The method utilizes a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the MYQ TestPak. Sample is then added onto the paper where it reacts with the immobilized anti-myoglobin antibody. After a short incubation, a conjugate consisting of enzyme-labeled antibody directed against a distinct antigenic site on the myoglobin molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzymelabeled antibody reacts with the bound myoglobin, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone of the TestPak. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of myoglobin in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
This device was previously cleared under K981102. Subsequently, the product insert has been modified to change the recommended frequency of quality control from daily to weekly.
Intended Use: The Myoglobin (MYO) TestPak used on the Stratus® CS STAT Fluorometric Analyzer is an in vitro diagnostic product for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin are used as aids in the rapid diagnosis of renal and heart disease, e.g. acute myocardial infarction.
{1}------------------------------------------------
Comparison to Predicate Device:
| Feature | Stratus CS® MYO (modified) | Stratus CS® MYO (K981102) |
|---|---|---|
| Principle of procedure | Two-site sandwich assay | Two-site sandwich assay |
| Type of measurement | Fluorometric | Fluorometric |
| Solid Phase | Glass fiber paper | Glass fiber paper |
| Sample Type | Heparinized plasma | Heparinized plasma |
| Recommended QC Frequency | At least once each week | At least daily |
| Intended Use | For the quantitativemeasurement of myoglobin | For the quantitativemeasurement of myoglobin |
| Indications for Use | For use as an aid in the rapiddiagnosis of renal and heartdisease, e.g. acute myocardialinfarction | For use as an aid in the rapiddiagnosis of renal and heartdisease, e.g. acute myocardialinfarction |
Comments on Substantial
Equivalence: Both assays are in vitro immunoassays with intended uses for the measurement of Myoglobin in heparinized plasma. The modified device differs from the device cleared under K981102 only in the recommended QC frequency in product labeling.
Conclusion: The QC data collected supports the recommended change in QC frequency and indicates the change will not adversely affect performance of the device.
Rebecca S. Apsh
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 11/13/98
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
DEC T 4 1998
Ms. Rebecca S. Ayash Requlatory Affairs and Compliance Manager Dade Behring Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
Re: K984065 Stratus® CS Myoglobin (MYO) TestPak Trade Name: Requlatory Class: II Product Code: DDR Dated: November 13, 1998 Received: November 16, 1998
Dear Ms. Ayash:
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 Requlations, 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 Reqister. 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
{3}------------------------------------------------
Page 2
This letter will allow you to beqin 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 requlation (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 requlation 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
{4}------------------------------------------------
Indications Statement
Device Name: Stratus® CS Myoglobin (MYO) TestPak
Indications for Use: The MYO TestPak used on the Stratus® CS STAT Fluorometric Analyzer is an in vitro diagnostic product for the measurement of Myoglobin in heparinized plasma. Measurements of Myoglobin are used as aids in the rapid diagnosis of renal or heart disease, e.g. acute myocardial infarction.
Rebecca S. Ayashi
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 11/13/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K9840i5
510(k) Number
510(k) Number
Division Sign-Off Office of Device Evaluation
prescription use
(Division Sign-Off)
Division of Clinical Laborator
510(k) Number. K984065
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).