(64 days)
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No
The summary describes a standard in vitro diagnostic assay for measuring drug concentration, with no mention of AI/ML terms, image processing, or data training/testing.
No
The device is an in vitro diagnostic procedure used to measure a drug's concentration, which helps monitor therapeutic levels but does not directly provide therapy.
Yes
The 'Intended Use / Indications for Use' explicitly states that it is an "in vitro diagnostic procedure".
No
The device is described as an in vitro diagnostic procedure for measuring digoxin concentration in serum and plasma on specific hardware systems (Technicon RA/opeRA systems), indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that this is an "in vitro diagnostic procedure" intended to measure the concentration of digoxin in human serum and plasma.
- Sample Type: It uses human serum and plasma, which are biological samples typically analyzed in vitro.
- Purpose: The purpose is to monitor drug levels for therapeutic management and toxicity avoidance, which is a common application of IVD tests.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KXT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison 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).
Key Results:
Minimum Det. Conc.: RA/opeRA = 0.20 ng/mL, Immuno 1 = 0.04 ng/mL
Precision (Total):
RA/opeRA: 20.0% @ 0.4ng/mL, 9.0% @ 1.3ng/mL, 9.0% @ 2.8ng/mL
Immuno 1: 8.2% @ 0.7ng/mL, 4.2% @ 2.2ng/mL, 3.6% @ 3.4ng/mL
Correlation: y=1.08x+0.11, where y=RA/opeRA, x=Immuno 1, n=39, r=0.949, Syx=0.2 ng/mL
Range of RA analyte concentration = 0,2 - 2.8 ng/mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum Det. Conc., Precision (Total), Correlation (r, Syx)
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.
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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.
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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).
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§ 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.
0
Image /page/0/Picture/2 description: The image shows the text 'P.2/10' at the top. Below this text is the handwritten text 'K980521'. The text is written in black ink on a white background. The handwriting is somewhat stylized, with the numbers being clearly distinguishable.
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. | Reagents | ||
| Calibrators | T-4H019 | ||
| T-4H209 | T01-2875-51 | ||
| T03-2864-01 | |||
| Minimum Det. Conc. | 0.20 ng/mL | 0.04 ng/mL | |
| Precision (Total) | 20.0% @ 0.4ng/mL | ||
| 9.0% @ 1.3ng/mL | |||
| 9.0% @ 2.8ng/mL | 8.2% @ 0.7ng/mL | ||
| 4.2% @ 2.2ng/mL | |||
| 3.6% @ 3.4ng/mL | |||
| Correlation | y=1.08x+0.11 | ||
| where | |||
| y=RA/opeRA | |||
| x=Immuno 1 | |||
| n=39 | |||
| r=0.949 | |||
| Syx=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
1
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.
2
Paqe 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/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
3
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