(64 days)
This in vitro diagnostic procedure is intended to quantitatively measure the concentration of digoxin in human serum and plasma on the Technicon RA/opeRA systems. Measurements obtained with this procedure are used to monitor circulating levels of this drug so that proper therapeutic level is maintained while avoiding toxicity.
Not Found
The provided text describes the performance of the Technicon RAM and opeRA Chemistry Systems Digoxin (using Syva Emit 2000* Reagents) in comparison to a predicate device (Bayer Immuno 1 Digoxin method), submitted for 510(k) clearance by the FDA.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The text doesn't explicitly state "acceptance criteria" but presents performance data for the new device (RA/opeRA) and the predicate device (Immuno 1) for comparison, implying that similar or better performance compared to the predicate is the expectation for clearance.
| Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (RA/opeRA) |
|---|---|---|
| Minimum Det. Conc. | 0.04 ng/mL | 0.20 ng/mL |
| Precision (Total) | 8.2% @ 0.7ng/mL4.2% @ 2.2ng/mL3.6% @ 3.4ng/mL | 20.0% @ 0.4ng/mL9.0% @ 1.3ng/mL9.0% @ 2.8ng/mL |
| Correlation | Range of RA analyte concentration = 0.2 - 2.8 ng/mL (This is a range, not a direct criterion) | y=1.08x+0.11 where y=RA/opeRA, x=Immuno 1 n=39 r=0.949 Syx=0.2 ng/mL |
Analysis of Performance vs. Implied Acceptance:
- Minimum Detection Concentration: The RA/opeRA system has a higher minimum detection concentration (0.2 ng/mL) compared to the Immuno 1 (0.04 ng/mL), suggesting it is less sensitive at very low concentrations.
- Precision: The RA/opeRA system shows worse precision (higher percentages) at all tested concentrations compared to the Immuno 1. For example, at its lowest tested concentration (0.4 ng/mL), it has 20.0% precision, whereas the Immuno 1 has 8.2% at 0.7 ng/mL.
- Correlation: The correlation coefficient (r=0.949) between the RA/opeRA and Immuno 1 methods, with n=39 samples and a Syx (standard error of the estimate) of 0.2 ng/mL, indicates a strong positive linear relationship, but the slope (1.08) and y-intercept (0.11) suggest a slight systematic difference from perfect agreement (y=x). The range of analyte concentration for the RA method (0.2 - 2.8 ng/mL) is also provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: For the correlation study, n=39 samples were used.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied the data was generated to support the 510(k) submission, likely in a controlled laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an in vitro diagnostic device measuring digoxin concentration using chemical reactions. The "ground truth" is established by the analytical measurement of the predicate device (Immuno 1), not by human experts interpreting images or clinical data.
4. Adjudication Method for the Test Set
Not applicable for an in vitro diagnostic device study of this nature. Ground truth is compared to a reference method, not adjudicated by experts in the typical sense.
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 study concerns an in vitro diagnostic device, not an AI-assisted diagnostic tool that would be interpreted by human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is a standalone diagnostic device (RA/opeRA system) without human-in-the-loop AI interpretation. Its performance is measured as described in the table against a predicate device.
7. The Type of Ground Truth Used
The "ground truth" for this study is the measurements obtained from a legally marketed predicate device (Bayer Immuno 1 Digoxin method). This method serves as the reference against which the new device's performance is compared for substantial equivalence.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. For in vitro diagnostic devices, development often involves extensive internal testing and optimization (which could be likened to training) but the 510(k) submission typically focuses on validation or comparison data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no information on a distinct "training set" or its ground truth establishment is provided. Device development and calibration would typically involve a series of known concentration standards and controls, but these are not explicitly detailed as a "training set" within this summary.
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SUMMARY OF SAFETY AND EFFECTIVENESS
Technicon RAM and opeRA Chemistry Systems Digoxin (Procedure Using Syva Emit 2000* Reagents)
Listed below is a companson of the performance between the Technicon RA/opeRA Digoxin method and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 1 Digoxin method). The information used in the Summary of Safety and Effectiveness was extracted from the RA/opeRA Digoxin method sheet and the Immuno 1 Digoxin method sheet.
INTENDED USE
This in vitro diagnostic procedure is intended to quantitatively measure the concentration of digoxin in human senum and plasma on the Technicon RA/opeRA systems. Measurements obtained with this procedure are used to monitor circulating levels of this drug so that proper therapeutic level is maintained while avoiding toxicity.
| METHOD | RA/opeRA | Immuno 1 | |
|---|---|---|---|
| Part No. | ReagentsCalibrators | T-4H019T-4H209 | T01-2875-51T03-2864-01 |
| Minimum Det. Conc. | 0.20 ng/mL | 0.04 ng/mL | |
| Precision (Total) | 20.0% @ 0.4ng/mL9.0% @ 1.3ng/mL9.0% @ 2.8ng/mL | 8.2% @ 0.7ng/mL4.2% @ 2.2ng/mL3.6% @ 3.4ng/mL | |
| Correlation | y=1.08x+0.11wherey=RA/opeRAx=Immuno 1n=39r=0.949Syx=0.2 ng/mL | Range of RA analyte concentration = 0,2 - 2.8 ng/mL |
Gabriel J. Munoz, Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation, BG-DS 511 Benedict Ave. Tarrytown, NY. 10591-5097 Tele. 914-524-3494
3/20/98
Date
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 2 1998
Gabriel Muraca, Jr. . Manager of Regulatory Affairs Baver Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
Re : K980521 Syva Emit® 2000 Digoxin Assay and Calibrator for the Technicon RA®/opeRA™ Systems Requlatory Class: II Product Code: KXT Dated: March 10, 1998 Received: March 12, 1998
Dear Mr. Muraca:
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 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 The general controls provisions of the Act 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 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 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 In addition, FDA may publish further announcements action. 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.
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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/dsmamain.html".
Sincerely yours,
Steven Litman
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
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Page 1 of 1
510(k) Number (if known): K982521
Device Name: Technicaon RA® and opeRA Chemistry Systems
Uring Suya Transis - Uning Suya Emit 2000* Reag Technicaon RA® and operes Casin 2000* Reagents)
Indications For Use:
This in viro diagnostic procedure is intended to measure the concentration of digoxin in human
RA-XT-1000 million the lates and 600® Technicon RA-1000®, Technicon RA-XTTM, serum or plasma on a Technicon RA-500®, Technicon RA-1000®, Technicon RA-XTM,
serum or plasma on a Technicon RA-500®, Technicon RA-1000®, Technicon RA-XTM, secure or plasma on a Technicon RA-500®, Technicon KA-1000%, Tourned with this procedure are used
Technicon RA-2000®, or opeRA system. Measurements obtained with this proced Technicon RA-2000®, or opeRA system. Measurements obtained with the proper theraped with the maintained while avoiding toxicity.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use L (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number GR953671
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.