(60 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring tobramycin levels using chemical reagents and a chemistry system. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
This device is for in vitro diagnostic use only, measuring tobramycin levels, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagent is "used in the diagnosis and treatment of tobramycin overdose."
No
The device description clearly outlines physical reagents, calibrators, and verifiers used in conjunction with a chemistry system (VITROS 5,1 FS Chemistry System). This indicates a hardware-dependent in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" for all three components: the reagent, the calibrator kit, and the performance verifier.
- Purpose: The device is used to quantitatively measure tobramycin concentration in human serum and plasma. This measurement is used in the diagnosis and treatment of tobramycin overdose and for monitoring therapeutic levels. This is a classic application of an in vitro diagnostic test.
- Components: The description details reagents, calibrators, and controls, which are all typical components of an in vitro diagnostic system.
- Predicate Device: The predicate device listed (SYVA® Emit® 2000 Tobramycin Assay and Calibrators) is also an in vitro diagnostic assay.
The information provided clearly indicates that this device is intended to be used outside of the body to examine specimens (serum and plasma) for diagnostic purposes.
N/A
Intended Use / Indications for Use
- For in vitro diagnostic use only. VITROS Chemistry Products TOBRA Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure tobramycin (TOBRA) concentration in human serum and plasma. Serum or plasma tobramycin measurements are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
- For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 14 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of tobramycin (TOBRA).
- For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and TOBRA on VITROS Chemistry Systems.
Product codes
LDO, DLJ, DIF
Device Description
The VITROS Chemistry Products TOBRA Reagent, VITROS Chemistry Products Calibrator Kit 14, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS TOBRA assay. VITROS Chemistry Products TOBRA Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure tobramycin.
VITROS Chemistry Products Calibrator Kit 14 and TDM Performance Verifiers are packaged and sold separately.
VITROS Chemistry Products Calibrator Kit 14 is a liquid ready to use calibrator set for tobramycin. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters.
VITROS Chemistry Products TDM Performance Verifier I, II and III are liquid ready to use controls with assayed values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).
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
In addition to the correlation studies, studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS TOBRA assay, (refer to the VITROS Chemistry Products TOBRA Reagent Instructions for Use for a summary of the results of these studies).
Key Metrics
Not Found
Predicate Device(s)
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
FEB - 7 2005 1.0 510(k) Summary
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.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
1.1 Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-3482 Fax: (585) 453-3368
Contact Person: Carey A. Mayo, M.S., RAC
1.2 Date of Preparation: December 8, 2004
1.3 Device Proprietary Name(s)
Trade Name(s):
VITROS Chemistry Products TOBRA Reagent
VITROS Chemistry Products Calibrator Kit 14
VITROS Chemistry Products TDM Performance Verifier I, II, and III
Common Name(s): Tobramycin assay and controls
1.4 Classification Name(s)
Tobramycin Test System: Class II (21 CFR 862.3900) Calibrators: Class II (21 CFR 862.3200) Assayed Controls: Class I (21 CFR 862. 3280)
1.5 Predicate device
The VITROS Chemistry Products TOBRA reagent and calibrators are substantially equivalent to the SYVA® Emit® 2000 Tobramycin Assay and Calibrators (Dade Behring, Inc.).
The VITROS Chemistry Products TDM Performance Verifiers are substantially equivalent to the previously cleared VITROS Chemistry Products TDM Performance Verifiers.
1
1.6 Device description
The VITROS Chemistry Products TOBRA Reagent, VITROS Chemistry Products Calibrator Kit 14, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS TOBRA assay. VITROS Chemistry Products TOBRA Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure tobramycin.
VITROS Chemistry Products Calibrator Kit 14 and TDM Performance Verifiers are packaged and sold separately.
VITROS Chemistry Products Calibrator Kit 14 is a liquid ready to use calibrator set for tobramycin. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters.
VITROS Chemistry Products TDM Performance Verifier I, II and III are liquid ready to use controls with assayed values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).
1.7 Device intended use(s)
VITROS Chemistry Products TOBRA Reagent: For in vitro diagnostic use only, VITROS Chemistry Products TOBRA Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure tobramycin (TOBRA) concentration in human serum and plasma. Serum or plasma tobramycin measurements are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
VITROS Chemistry Products Calibrator Kit 14: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 14 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of tobramycin (TOBRA).
VITROS Chemistry Products TDM Performance Verifier I, II and III: For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and TOBRA on VITROS Chemistry Systems.
2
1.8 Comparison to predicate device: Reagent and Calibrators
The VITROS Chemistry Products TOBRA Reagent and VITROS Chemistry Products Calibrator Kit 14 are substantially equivalent to the SYVA Emit 2000 Tobramycin Assay and the SYVA Emit 2000 Tobramycin Calibrators, which were cleared by FDA (K003341) for IVD use.
The relationship between the VITROS TOBRA assay and the predicate device, determined by least squares linear regression, is:
VITROS TOBRA assay = 1.01 X + 0.00 µg/mL, with a correlation coefficient of 0.997, where X is the predicate device.
In addition to the correlation studies, studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS TOBRA assay, (refer to the VITROS Chemistry Products TOBRA Reagent Instructions for Use for a summary of the results of these studies).
The table below lists the characteristics of the VITROS Chemistry Products TOBRA assay and the predicate device.
| Device
Characteristic | VITROS TOBRA Assay
(New device) | SYVA Emit 2000 Tobramycin Assay
(Predicate device) |
|--------------------------|-------------------------------------------|-------------------------------------------------------|
| Intended Use | Quantitative measurement of
tobramycin | Quantitative measurement of
tobramycin |
| Basic principle | Homogeneous enzyme
immunoassay | Homogeneous enzyme immunoassay |
| Reportable
Range | 0.6 – 10 µg/mL | 0.6 – 10 µg/mL |
| Reagents | Liquid ready to use | Liquid ready to use |
| Instrumentation | VITROS 5,1 FS Chemistry
System | SYVA-30R Biochemical System |
| Sample type | Serum and plasma | Serum and plasma |
1.9 Comparison to predicate device: Performance Verifiers
The VITROS Chemistry Products TDM Performance Verifiers are identical in intended use, base matrix, storage and handling and instructions for use as the previously cleared VITROS Chemistry Products TDM Performance Verifiers (K042476). The labeling will be updated to add assigned values for tobramycin so that the TDM Performance Verifiers may be used with the VITROS Chemistry Products TOBRA assay.
3
1.10 Conclusions
The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products TOBRA reagent, VITROS Chemistry Products Calibrator Kits 14, and the VITROS Chemistry Products TDM Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
FEB - 7 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Carey A. Mayo, MS., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. Regulatory Affairs MC00881 100 Indigo Creek Drive Rochester, NY 14626
Re: K043384
Trade/Device Name: VITROS Chemistry Products TOBRA Reagent VITROS Chemistry Products Calibrator Kit 14 VITROS Chemistry Products TDM Performance Verifiers I, II, and III
Regulation Number: 21 CFR 862.3900 Regulation Name: Tobramycin test system Regulatory Class: Class II Product Code: LDO, DLJ, DIF Dated: December 8, 2004 Received: December 9, 2004
Dear Ms. Mayo:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices 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 devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are 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 devices 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).
5
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.
Sean McCooper MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
2.0 Indications for Use
Page 1 of 1
| 510(k) Number (if known): | K043384 |
|---|---|
| Device Name: | 1. VITROS Chemistry Products TOBRA Reagent |
- VITROS Chemistry Products Calibrator Kit 14
- VITROS Chemistry Products TDM Performance Verifiers I, II, and III |
| Indications for Use: | 1. For in vitro diagnostic use only. VITROS Chemistry Products TOBRA Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure tobramycin (TOBRA) concentration in human serum and plasma. Serum or plasma tobramycin measurements are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy. - For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 14 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of tobramycin (TOBRA).
- For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and TOBRA on VITROS Chemistry Systems. |
| Prescription Use | AND/OR Over-The-Counter Use |
(Part 21 CFR 801 Subpart D)
(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. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation a nd Safety
510(k) K043384
VITROS Chemistry Products TOBRA assay and Controls Ortho-Clinical Diagnostics, Inc.
Page 5 of 45