(152 days)
Not Known
Not Found
No
The device description details a competitive immunoassay using chemiluminescence, a standard laboratory technique. There is no mention of AI, ML, or any computational algorithms beyond basic data processing for calculating concentrations from RLUs.
No
The device is an in-vitro diagnostic assay used for quantitative determination of digitoxin in serum or plasma. It helps monitor drug levels to maintain therapeutic efficacy and avoid toxicity, but it does not directly perform therapeutic action itself.
Yes
The device aids in monitoring serum digitoxin concentrations to adjust patient dosage, achieve optimal therapeutic effect, and avoid harmful toxic doses, which are all diagnostic activities.
No
The device is a competitive immunoassay using direct, chemilumenescent technology, which involves physical reagents (paramagnetic particles, acridinium ester-labeled monoclonal antibody) and a hardware system (ACS:180 Automated Chemiluminescence System) to measure relative light units. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of digitoxin in serum or plasma." Serum and plasma are biological samples taken from the human body.
- Method: The device uses a "competitive immunoassay" and "chemiluminescence technology" to measure the substance (digitoxin) in these biological samples.
- Purpose: The purpose is to "monitor serum digitoxin concentrations" to "maintain therapeutic efficacy and avoid toxicity," which directly relates to diagnosing, monitoring, or treating a medical condition (in this case, related to digitoxin levels and their effects).
These characteristics align perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
For the auantitative determination of dicitoxin in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.
The Chiron Diagnostics ACS:180 Digitoxin Assay is for the quantitative determination of digitoxin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence System. Monitoring of serum digitoxin concentrations is necessary to maintain therapeutic efficacy and avoid toxicity. Serum digitoxin levels combined with other therapeutic data provide the clinician with useful information to aid in adjusting patient dosage, achieving optimal therapeutic effect, and avoiding useless subtherapeutic or harmful toxic doses.
Product codes (comma separated list FDA assigned to the subject device)
LFM
Device Description
The Chiron Diagnostics ACS:180 Digitoxin assay is a competitive immunoassay using direct, chemilumenescent technology. Digitoxin in the patient sample competes with digitoxin, which is covalently coupled to the paramagnetic particles in the Solid Phase for binding to the acridinium ester-labeled monoclonal anti-digitoxin antibody in the Lite Reagent. An inverse relationship exists between the amount of digitoxin in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.
The Chiron Diagnostics ACS Digitoxin assay is a competitive chemiluminescent immunoassay.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sensitivity: The ACS Digitoxin immunoassay measures digitoxin concentration up to 80 nq/mL with a minimum detectable concentration of 1 5 no/mL.
Accuracy: For 608 samples in the range of 1 5 to 60 no/mL, the correlation between the ACS:180 Digitoxin and an alternate fluorescence polarization (FPIA) method is described by the equation: ACS:180 Digitoxin = 0.79 (alternate method) + 4.9 ng/m] Correlation coefficient (r) = 0.83
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: The ACS Digitoxin immunoassay measures digitoxin concentration up to 80 nq/mL with a minimum detectable concentration of 1 5 no/mL.
Accuracy: Correlation coefficient (r) = 0.83
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.
Not Known
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.
Not Found
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).
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
970546
JUL 1 4 1997
Class II Digitoxin Test System, 21 CFR 862.3300
Company Confidential
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
| Contact person: | Thomas F. Flynn |
|---|---|
| Address: | Chiron Diagnostics Corporation |
| 63 North Street | |
| Medfield, MA 02052 | |
| Phone: (508) 359-3877 | |
| FAX: (508) 359-3885 | |
| e-mail: thomas.flynn@chirondiag.com | |
| Date Summary Prepared: | January 31, 1997 |
| Device Information | |
| Proprietary Name: | |
| Common Name: | ACS Digitoxin |
| Digitoxin Immunoassay |
3. Predicate Device Information
| Name: | TDX Digitoxin Immunoassay |
|---|---|
| Manufacturer: | Abbott Laboratories |
| 510(k) Number: | Not Known |
4. Device Description
Classification Name:
The Chiron Diagnostics ACS:180 Digitoxin assay is a competitive immunoassay using direct, chemilumenescent technology. Digitoxin in the patient sample competes with digitoxin, which is covalently coupled to the paramagnetic particles in the Solid Phase for binding to the acridinium ester-labeled monoclonal anti-digitoxin antibody in the Lite Reagent. An inverse relationship exists between the amount of digitoxin in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.
1
K 970546
Company Confidential
5. Statement of Intended Use
For the auantitative determination of dicitoxin in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.
Summary of Technological Characteristics 6.
The Chiron Diagnostics ACS Digitoxin assay is a competitive chemiluminescent immunoassay.
7. Performance Data
Sensitivity
The ACS Digitoxin immunoassay measures digitoxin concentration up to 80 nq/mL with a minimum detectable concentration of 1 5 no/mL.
Accuracy
For 608 samples in the range of 1 5 to 60 no/mL, the correlation between the ACS:180 Digitoxin and an alternate fluorescence polarization (FPIA) method is described by the equation:
ACS:180 Digitoxin = 0.79 (alternate method) + 4.9 ng/m]
Correlation coefficient (r) = 0.83
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thomas F. Flynn Manager, Regulatory Affairs & Compliance _ Chiron Diagnostics Corporation ... ........................................................................................................................................... 63 North Street Medfield, Massachusetts 02052-1688
JUL 1 4 1997
K970546 Re : ACS Diqitoxin Immunoassay Regulatory Class: II Product Code: LFM Dated: June 26, 1997 Received: June 27, 1997
Dear Mr. Flynn:
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, Druq, 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 requirement, 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 requlation 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 Requlations.
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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 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Ditman
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 _ of _
510(k) Number (if known):
Device Name: Chiron Diagnostics ACS:180 Digitoxin Assay ____
Indications for Use:
The Chiron Diagnostics ACS:180 Digitoxin Assay is for the quantitative determination of digitoxin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence ulytoxin in Coram of placing of serum digitoxin concentrations is necessary to maintain Systementic efficacy and avoid toxicity. Serum digitoxin levels combined with other therepodite chicaly are clinician with useful information to aid in adjusting patient dosage, achieving optimal therapeutic effect, and avoiding useless subtherapeutic or harmful toxic doses.
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | Ka K970546 |
(FLEASE DO NOT WRITE BEI.OW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
(Optional Format 1-2-96)