(21 days)
The MYO Calibrator is intended to be used to calibrate the MYO Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
MYO Calibrator is a five level liquid bovine serum albumin-based product with target concentrations of 0, 35, 100, 500, and 1060 ng/ml. Level 1 contains no detectable myoglobin. Levels 2 through 5 contain human heart myoglobin. The kit consists of ten vials; two at each level
This document describes the Dade Behring Dimension® RxL Myoglobin (MYO) Calibrator, a secondary calibrator intended for use with the Dimension® RxL clinical chemistry system.
Based on the provided text, the device is a calibrator, not a diagnostic device that generates performance metrics like sensitivity, specificity, or AUC. Calibrators are used to establish a reference point for an assay, ensuring accurate quantitative measurements. Therefore, the concept of "acceptance criteria" and "device performance" in the typical sense (e.g., detecting a disease) does not directly apply here. Instead, the "study" demonstrating its effectiveness would likely involve showing that the calibrator functions correctly to enable accurate calibration of the Myoglobin (MYO) Method.
Given that this is a 510(k) submission primarily for demonstrating substantial equivalence to a predicate device, the "study" would focus on comparing the characteristics and performance of the new calibrator to an already legally marketed one.
Here's an attempt to answer your questions based on the available information, with caveats due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
Since this is a calibrator, "acceptance criteria" likely relate to its composition, stability, and its ability to properly calibrate the associated assay, leading to accurate Myoglobin measurements. The provided document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics from a specific study on the calibrator itself beyond the comparison to the predicate.
| Acceptance Criteria (Implied for a Calibrator) | Reported Device Performance (from comparison to predicate) |
|---|---|
| Fulfills intended use as a calibrator | Calibrator |
| Contains human heart myoglobin as analyte | Human heart myoglobin |
| Matrix is bovine serum albumin | Bovine serum albumin |
| Form is liquid | Liquid |
| Target concentrations for calibration are appropriate | 0, 35, 100, 500, 1060 ng/mL |
| Number of levels is suitable for calibration | Five |
| Substantially equivalent to predicate device | Found "substantially equivalent" |
Note: The "reported device performance" here is largely based on direct comparison of characteristics to the predicate device, not on extensive performance data for the calibrator itself. The "substantial equivalence" determination by the FDA implies that the new calibrator is expected to perform comparably to the predicate in its intended function.
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 describe a "test set" in the traditional sense of evaluating a diagnostic algorithm. The comparison is primarily between the characteristics of the new calibrator and the predicate calibrator. There is no mention of sample size, data provenance, or retrospective/prospective nature for evaluating the calibrator's performance beyond its intrinsic properties.
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 a calibrator, not a diagnostic tool requiring expert interpretation of results to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or adjudication process described for this calibrator.
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 a calibrator, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical calibrator, not an algorithm, so "standalone performance" of an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a calibrator, the "ground truth" would be the known, verified concentrations of myoglobin within each calibrator level. The text states:
- "Level 1 contains no detectable myoglobin."
- "Levels 2 through 5 contain human heart myoglobin."
- "Target Concentrations: 0, 35, 100, 500, 1060 ng/mL."
This indicates that these concentrations are designed and verified by the manufacturer, rather than being derived from external expert consensus, pathology, or outcomes data in the context of diagnostic evaluation.
8. The sample size for the training set
Not applicable. This is a calibrator, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable for the same reason as above. The "ground truth" for the calibrator levels themselves would be established through precise manufacturing processes and analytical verification of the myoglobin concentrations within each vial.
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DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
DADE BEHRING K984193
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. Ayash |
|---|---|
| Dade Behring Inc. | |
| Building 500, Mailbox 514 | |
| P.O. Box 6101 | |
| Newark, DE 19714-6101 | |
| Phone: | (302) 631-6276 |
| FAX: | (302) 631-6299 |
Date of Preparation: 11/20/98
Device Name: Dimension® RxL Myoglobin (MYO) Calibrator
Classification Name: Calibrator, secondary
Dade Behring Stratus® Myoglobin Calibrator Predicate Device:
Device Description: MYO Calibrator is a five level liquid bovine serum albumin-based product with target concentrations of 0, 35, 100, 500, and 1060 ng/ml. Level 1 contains no detectable myoglobin. Levels 2 through 5 contain human heart myoglobin. The kit consists of ten vials; two at each level
Intended Use: The MYO Calibrator is intended to be used to calibrate the MYO Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
Comparison to Predicate Device:
| Dimension® RxL MYO Calibrator | Stratus® Myoglobin Calibrator | |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analyte | Human heart myoglobin | Human heart myoglobin |
| Matrix | Bovine serum albumin | Bovine serum albumin |
| Form | Liquid | Liquid |
| TargetConcentrations(ng/mL) | 0, 35, 100, 500, 1060 | 0, 35, 100, 300, 500, 1000 |
| Levels | Five | Six |
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a symbol that resembles a stylized caduceus, with three lines representing snakes intertwined around a staff. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 4 1998 Ms. Rebecca S. Ayash Requlatory Affairs and Compliance Manager Dade Behring Buildinq 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101
Re: K984193 Dimension® RxL Myoglobin (MYO) Calibrator Trade Name: Requlatory Class: II Product Code: JIT Dated: November 20, 1998 Received: November 23, 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 leqally 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 (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 obliqation 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.
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Paqe 2
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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Indications Statement
Device Name: Dimension® RxL Myoglobin (MYO) Calibrator
Indications for Use: The Dimension® RxL Myoglobin (MYO) Calibrator is intended to be used to calibrate the Myoglobin Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
Rebecca Suysh
Rebecca S. Ayash
Rebecca S. Ayast Regulatory Affairs and Compliance Manager Date: 11/20/98
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Concurrence of CDRH, Office of Device Evaluation (ODE)
K984193
510(k) Number
0(k) Number
Division Sign-Off
Office of Device Evatuation
\prescription use
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.