(63 days)
No
The description details a standard immunoassay technique for measuring digitoxin levels, relying on chemical reactions and absorbance measurements. There is no mention of AI or ML in the device description, performance studies, or key metrics.
No.
The device is an in vitro diagnostic device used to measure digitoxin levels, which aids in diagnosis and monitoring therapy, not directly treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "The DGTX Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device". It also mentions "Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose".
No
The device description clearly outlines a reagent cartridge and an immunoassay technique involving physical components like magnetic particles, antibodies, and substrates, which are hardware and chemical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The DGTX Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure digitoxin in human serum and plasma."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DGTX Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure digitoxin in human serum and plasma. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.
Product codes
LFM
Device Description
The digitoxin assay uses an immunoassay technique in which free and digitoxin-bound antibody-enzyme species are separated using magnetic particles. Digitoxin in the sample is bound by the F(ab')2-ß-galactosidase in the Antibody Conjugate reagent. Magnetic particles coated with the digitoxin analog ouabain are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the digitoxin-antibody-enzyme complex is transferred and mixed with a substrate. The ß-galactosidase (ß-gal) portion of the Digoxin-F(ab')2-βgalactosidase complex catalyzes the hydrolysis of chlorophenol red-β-D galactopyranoside (CPRG) to chlorophenol red (CPR). The change in absorbance at 577 nm due to the formation of CPR is directly proportional to -B-galactosida: e activity. Since ß-galactosidase is not present in serum, its activity is directly proportional to di ¿itoxin in the patient's sample and is measured using a bichromatic (577, 700 nm) rate technique.
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
Split sample comparison between the DGTX Flex™ reagent cartridge on the Dimension® clinical chemistry system and the aca® DGTX assay gave a correlation coefficient of 0.952, slope of 1.06, and an intercept of -0.6 when tested with 93 clinical patient samples.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3300 Digitoxin test system.
(a)
Identification. A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.(b)
Classification. Class II.
0
3/31/99
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: | Cathy P. Craft
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------|
| Date of Preparation: | 1/22/99 |
| Name of Product: | DGTX Flex™ reagent cartridge |
| FDA Classification Name: | Digitoxin Test System |
| Predicate Device: | aca® Digitoxin Method (K891094) |
Device Description: The digitoxin assay uses an immunoassay technique in which free and digitoxin-bound antibody-enzyme species are separated using magnetic particles. Digitoxin in the sample is bound by the F(ab')2-ß-galactosidase in the Antibody Conjugate reagent. Magnetic particles coated with the digitoxin analog ouabain are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the digitoxin-antibody-enzyme complex is transferred and mixed with a substrate. The ß-galactosidase (ß-gal) portion of the Digoxin-F(ab')2-βgalactosidase complex catalyzes the hydrolysis of chlorophenol red-β-D galactopyranoside (CPRG) to chlorophenol red (CPR). The change in absorbance at 577 nm due to the formation of CPR is directly proportional to -B-galactosida: e activity. Since ß-galactosidase is not present in serum, its activity is directly proportional to di ¿itoxin in the patient's sample and is measured using a bichromatic (577, 700 nm) rate technique.
Intended Use: The DGTX Flex™ reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure digitoxin (DGTX) in human serum and plasma.
Comparison to Predicate Device:
| Item | Dimension® DGTX | aca® DGTX |
|---|---|---|
| Sample Type | serum and plasma | serum |
| Antibody | monoclonal | polyclonal |
| Methodology | Affinity particle | |
| mediated immunoassay | Affinity column | |
| mediated immunoassay | ||
| Detection | Bichromatic rate | |
| (577 and 700 nm) | Monochromatic rate | |
| (405 nm) |
1
Comments on Substantial Equivalence:
Split sample comparison between the DGTX Flex™ reagent cartridge on the Dimension® clinical chemistry system and the aca® DGTX assay gave a correlation coefficient of 0.952, slope of 1.06, and an intercept of -0.6 when tested with 93 clinical patient samples.
The DGTX Flex™ reagent cartridge is substantially equivalent in principle and Conclusion: performance to the aca® DGTX assay based on the split sample comparison discussed above.
Cathy P. Craft
Cathy P. Craft Regulatory Affairs and Compliance Manager Date:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
MAR 3 1 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cathy P. Craft Regulatory Affairs and Compliance Manager DADE BEHRING, INC. P.O. Box 6101 Newark, Delaware 19714
K990251 Re:
Trade Name: Digitoxin (DGTX) Flex™ Reagent Cartridge Regulatory Class: II Product Code: LFM Dated: January 22, 1999 Received: January 27, 1999
Dear Ms. Craft:
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 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.
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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 Sutman
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 For Use Statement
Device Name: DGTX Flex™ reagent cartridge
Indications for Use:
The DGTX Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure digitoxin in human serum and plasma. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.
Sean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices K 990251 510(k) Number
Cathy P. Craft Regulatory Affairs and Compliance Manager
January 22, 1999
(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)