(112 days)
Not Known
Not Found
No
The device description details a competitive immunoassay based on chemiluminescence and antibody binding. There is no mention of AI, ML, or any computational algorithms beyond standard data processing for calculating concentration from light units. The performance studies focus on analytical sensitivity and correlation with a predicate device, not on the performance of an AI/ML model.
No.
The device is an in vitro diagnostic (IVD) assay designed to measure tobramycin levels, which is used for monitoring drug concentrations. It does not directly provide therapy or affect the body's structure or function to treat or mitigate a disease.
Yes
The device quantitatively determines tobramycin in serum or plasma to monitor therapeutic concentrations and avoid toxicity, which directly aids in diagnosis and patient management.
No
The device description clearly outlines a competitive immunoassay using reagents (Lite Reagent, Solid Phase) and paramagnetic particles, which are physical components, not software. The device relies on a chemiluminescence system (ACS:180 Automated Chemiluminescence Systems) to detect relative light units (RLUs), indicating a hardware component is essential to its function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of tobramycin in serum or plasma". Serum and plasma are biological samples taken from the human body.
- Device Description: The device description details a "competitive immunoassay" that uses "patient sample" (serum or plasma) to measure the concentration of tobramycin. This is a typical method for in vitro diagnostic testing.
- Purpose: The purpose of the test is to "monitor the patient's serum or plasma tobramycin levels," which is done outside of the body to provide information for medical diagnosis or treatment.
These points clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
For the quantitative determination of tobramycin in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.
The Chiron Diagnostics ACS:180 Tobramycin Assay is for the quantitative determination of tobramycin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence Systems. Monitoring the patient's serum or plasma tobramycin levels is important both to ensure that the drug is present in therapeutic concentrations and to avoid toxicity.
Product codes
LCR
Device Description
The Chiron Diagnostics ACS:180 Tobramycin assay is a competitive immunoassay using direct, chemilumenescent technology. Tobramycin in the patient sample competes with acradinium ester-labeled tobramycin in the Lite Reagent for a limited amount of monoclonal mouse anti-tobramycin antibody, which is covalently coupled to the paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of tobramycin present in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.
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 Tobramycin immunoassay measures tobramycin concentration up to 13 ug/mL with a minimum detectable concentration of 0.18 µg/mL.
Accuracy: For 293 samples in the range of 0.22 to 9.03 ug/mL, the correlation between the ACS:180 Tobramycin and an atternate fluorescence polarization (FPIA) method is described by the equation: ACS:180 Tobramycin = 0.903 (alternate method) + 0.10 µg/mL. Correlation coefficient (r) = 0.99
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: minimum detectable concentration of 0.18 µg/mL.
Accuracy: Correlation coefficient (r) = 0.99
Predicate Device(s)
Not Known
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3900 Tobramycin test system.
(a)
Identification. A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.(b)
Classification. Class II.
0
CHIRON LEGAL
I. Following is the revised Summary of Safety and Effectiveness:
Summary of Safety and Effectiveness
FE: ? ""
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
FEB 1 2 1998
Contact person:
Thomas F. Flynn
September 11, 1997
Address: 63 North Street Medfleld, MA 02052
Phone: FAX: e-mail:
(508) 359-3877
Chiron Diagnostics Corporation
(508) 359-3885 thomas.flynn@chirondiag.com
Date Summary Prepared:
2. Device Information
Proprietary Name: Common Name: Classification Name: ACS Tobramycin Tobramycin Immunoassay Class II Tobramycin Test System, 21 CFR 862.3900
3. Predicate Device Information
| Name: | TDX/FLx Tobramycin Immunoassay |
|---|---|
| Manufacturer: | Abbott Laboratories |
| 510(k) Number: | Not Known |
4. Device Description
The Chiron Diagnostics ACS:180 Tobramycin assay is a competitive immunoassay using direct, chemilumenescent technology. Tobramycin in the patient sample competes with acradinium ester-labeled tobramycin in the Lite Reagent for a limited amount of monoclonal mouse anti-tobramycin antibody, which is covalently coupled to the paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of tobramycin present in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.
1
5. Statement of Intended Use
For the quantitative determination of tobramycin in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.
6. Summary of Technological Characteristics
The Chiron Dlagnostics ACS Tobramycin assay is a competitive chemiluminescent immunoassay.
7. Performance Data
Sensitivity
The ACS Tobramycin immunoassay measures tobramycin concentration up to 13 ug/mL with a minimum detectable concentration of 0.18 µg/mL.
Accuracy
For 293 samples in the range of 0.22 to 9.03 ug/mL, the correlation between the ACS:180 Tobramycin and an atternate fluorescence polarization (FPIA) method is described by the equation:
ACS:180 Tobramycin = 0.903 (alternate method) + 0.10 µg/mL
Correlation coefficient (r) = 0.99
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thomas F. Flynn Manager, Regulatory Affairs & Compliance CHIRON DIAGNOSTICS CORPORATION 63 North Street Medfield, MA 02052
FEB 1 2 1998
Re: K974029 Trade Name: ACS Tobramycin Regulatory Class: II Product Code: LCR 91 Dated: December 23, 1997 Received: December 24, 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 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 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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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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
Company Confidential
Page _ of _
510(k) Number (if known): K974029
Device Name: Chiron Diagnostics ACS:180 Tobramycin Assay
Indications for Use: -----------------------
The Chiron Diagnostics ACS:180 Tobramycin Assay is for the quantitative determination of tobramycin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence Systems. Monitoring the patient's serum or plasma tobramycin levels is important both to ensure that the drug is present in therapeutic concentrations and to avoid toxicity.
Andhut In AWM
(Division Sign-Off)
Division of Clinical Laboratory Devices 19974029
(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE, IFF. -----NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
510(k) Number
Over-The-Counter Use (Optional Format 1-2-96)
ACS:180 Tobramycin 510(k)
22 October, 1997