(29 days)
Not Found
No
The description focuses on a standard immunoassay for measuring drug levels and does not mention any AI/ML components or functionalities.
No
This device is an in vitro diagnostic (IVD) assay designed to measure digoxin levels in patient samples, which assists in monitoring therapy and treating overdose. It does not directly provide therapy or interact with the patient's body for therapeutic purposes.
Yes
This device is a microparticle enzyme immunoassay (MEIA) used for the quantitative measurement of digoxin in serum or plasma. These measurements are used in the treatment of digoxin overdose and for monitoring digoxin levels to ensure appropriate therapy, which falls under diagnostic purposes.
No
The device description clearly outlines physical reagent components (reagent pack, calibrators, controls) which are not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of digoxin... in serum or plasma." This is a classic example of an in vitro test performed on biological samples outside the body.
- Device Description: The description details reagents and calibrators used to perform the test on these samples.
- Performance Studies: The summary of performance studies refers to "laboratory testing," further indicating an in vitro process.
The core function of the device is to analyze a biological sample (serum or plasma) to provide diagnostic information (digoxin levels), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AxSYM Digoxin III assay is a microparticle enzyme immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
KXT, JIT, JJT, JJX
Device Description
The AxSYM Digoxin III Reagent Pack is composed of the following reagent components:
• Digoxin: Alkaline Phosphatase Conjugate
• Anti-digoxin (Rabbit) Coated Microparticles
• MEIA Buffer
• Digoxin III Probe Wash Solution
The AxSYM Digoxin III Calibrators contain six bottles of accurately measured amounts of digoxin prepared in recalcified human plasma, nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2.
The AxSYM Digoxin III Controls contain three bottles of accurately measured amounts of digoxin prepared in recalcified human plasma, nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.3 ng/mL (0.38 nmol/L)
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.
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
§ 862.3320 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
JUN - 2 2006
Special 510(k) Summary
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
According to the requirements of 21 CFR §807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equipalence.
| Submitter's Name and Address: | Abbott Laboratories
Diagnostics Division
100 Abbott Park Road
Abbott Park, Illinois 60064-3500
Telephone: (847) 938-4807
Fax: (847) 937-9616
Contact: Kenton.Smith@abbott.com |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 2006 |
| Device Proprietary Name:
Device Common Name:
Classification Number: | AxSYM® Digoxin III
Digoxin
Toxicology, 21 CFR §862.3320 |
| Predicate Device: | AxSYM Digoxin II
510(k) Number: K953718 |
| Device Description: | The AxSYM Digoxin III Reagent Pack is
composed of the following reagent components:
• Digoxin: Alkaline Phosphatase Conjugate
• Anti-digoxin (Rabbit) Coated Microparticles
• MEIA Buffer
• Digoxin III Probe Wash Solution |
| | The AxSYM Digoxin III Calibrators contain six
bottles of accurately measured amounts of
digoxin prepared in recalcified human plasma,
nonreactive for HBsAg, HIV-1 RNA or HIV-1
Ag, anti-HCV, and anti-HIV-1/HIV-2. |
| | The AxSYM Digoxin III Controls contain three
bottles of accurately measured amounts of
digoxin prepared in recalcified human plasma,
nonreactive for HBsAg, HIV-1 RNA or HIV-1
Ag, anti-HCV, and anti-HIV-1/HIV-2. |
1
Intended Use:
The AxSYM Digoxin III assay is a microparticle enzyme immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.
Comparison to Predicate Device:
| Attribute | AxSYM Digoxin II
Predicate Device | AxSYM Digoxin III
Modified Device |
|-------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------|
| Analyte Measured | Digoxin | Same |
| Assay Principle | MEIA technology,
competitive format | Same |
| Instrumentation | Abbott AxSYM Analyzer | Same |
| Sample Type | Serum or plasma | Same |
| Sample Volume | 150 µL (Routine)
131 µL (STAT) | 194 µL (Routine and STAT) |
| Sample Pretreatment | No | No |
| Assay Type | Quantitative | Same |
| Dynamic Range | 0.0 to 4.0 ng/mL (0.00 to
5.12 nmol/L) | Same |
| Calibrator Values | 0.0, 0.5, 1.0, 2.0, 3.0, and 4.0
ng/mL (0.00, 0.64, 1.28,
2.56, 3.84, and 5.12 nmol/L) | Same |
| Control Values | 0.9, 1.9, and 3.2 ng/mL
(1.15, 2.43, and 4.10 nmol/L) | Same |
| Sensitivity | 0.3 ng/mL (0.38 nmol/L) | Same |
| Immunoassay Format | 2-step | 1-step |
| Saponin (%) in Conjugate
Diluent | 0.13 | 0.3 |
| Antibody | Rabbit Polyclonal | Same |
| Conjugate | Digoxin: Alkaline
Phosphatase | Same |
2
| Bilirubin Interference at
| 20 mg/dL | Less than 10% | Less than 20% |
|---|---|---|
| Drug Compound | ||
| Interference (Aldosterone | ||
| inhibitors and other | ||
| steroids) | -33% to -3% | -2% to 2% |
| Probe Wash Solution | ||
| Ingredients | 2 M sodium chloride | |
| 0.1% sodium azide | 2 M sodium chloride | |
| 0.1% sodium azide | ||
| 0.5% Triton X-100 | ||
| 0.05% antifoam | ||
| Medium Control Range | ||
| (Target: 1.9 ng/mL) | 1.50 to 2.30 ng/mL | 1.43 to 2.38 ng/mL |
| High Control Range | ||
| (Target: 3.2 ng/mL) | 2.60 to 3.80 ng/mL | 2.50 to 3.90 ng/mL |
Conclusion: Results of laboratory testing demonstrate that the performance of the Abbott AxSYM Digoxin III assay is acceptable and comparable to the performance of the predicate device, when used according to its intended use.
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol. The text and the bird are in black and the background is white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Kenton L. Smith Senior Regulatory Affairs Specialist Abbott Laboratories Dept. 9VA, Bldg AP6C-2 100 Abbott Park Road Abbott Park, Illinois 60064-3500
JUN - 2 2006
Re: K061249
Trade/Device Name: AxSYM® Digoxin III Regulation Number: 21 CFR§ 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: KXT, JIT, JJT, JJX Dated: May 3, 2006 Received: May 4, 2006
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutz
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K061249
Device Name: AxSYM® Digoxin III
Indications For Use:
The AxSYM Digoxin III assay is a microparticle enzyme immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benam
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
310(k) K061249