(115 days)
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No
The summary describes a standard in vitro diagnostic assay for measuring gentamicin levels using chemical reagents and a chemistry system. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is for in vitro diagnostic use only, designed to measure gentamicin levels in human serum and plasma. It is not intended for direct treatment or therapy in patients.
Yes
The "Intended Use / Indications for Use" section explicitly states "VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy." This clearly indicates its role in diagnosis and treatment monitoring.
No
The device description clearly outlines physical reagents, calibrators, and verifiers, which are hardware components used in an in vitro diagnostic assay. It also mentions the VITROS 5,1 FS Chemistry System, which is a hardware instrument.
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 (Reagent, Calibrator Kit, and Performance Verifier).
- Measurement of Substance in Human Sample: The intended use is to "quantitatively measure gentamicin (GENT) concentration in human serum and plasma." This is a key characteristic of an in vitro diagnostic device, as it analyzes a sample taken from the human body.
- Clinical Purpose: The measurements are used "in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy." This demonstrates a clinical purpose for the test results, which is another defining feature of an IVD.
- Device Description: The description details reagents, calibrators, and controls used to perform an assay on a chemistry system, all of which are typical components of an in vitro diagnostic test system.
N/A
Intended Use / Indications for Use
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- VITROS Chemistry Products GENT Reagent: For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
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- VITROS Chemistry Products Calibrator Kit 13: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT).
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- 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 GENT on VITROS Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
LCD, DLJ, DIF
Device Description
The VITROS Chemistry Products GENT Reagent. VITROS Chemistry Products Calibrator Kit 13, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS GENT assay. VITROS Chemistry Products GENT Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure gentamicin.
VITROS Chemistry Products Calibrator Kit 13 and TDM Performance Verifiers are packaged and sold separately.
VITROS Chemistry Products Calibrator Kit 13 is a liquid ready to use calibrator set for gentamicin. 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS GENT assay. The relationship between the VITROS GENT assay and the predicate device, determined by least squares linear regression, is: VITROS GENT assay = 1.00 X - 0.0138 ug/mL, with a correlation coefficient of 0.993, where X is the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient of 0.993.
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.
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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
§ 862.3450 Gentamicin test system.
(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.
0
JAN - 6 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: K042479
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: September 9, 2004
1.3 Device Proprietary Name(s)
Trade Name(s): VITROS Chemistry Products GENT Reagent VITROS Chemistry Products Calibrator Kit 13 VITROS Chemistry Products TDM Performance Verifier I, II, and III
Common Name(s): Gentamicin assay and controls
1.4 Classification Name(s)
Gentamicin Test System: Class II (21 CFR 862.3450) Calibrators: Class II (21 CFR 862.3200) Assayed Controls: Class I (21 CFR 862. 3280)
1.5 Predicate device
The VITROS Chemistry Products GENT reagent and calibrators are substantially equivalent to the SYVA® Emit® 2000 Gentamicin Plus Assay and Gentamicin Plus Calibrators (Dade Behring, Inc.).
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The VITROS Chemistry Products TDM Performance Verifiers are substantially equivalent to the VITROS Chemistry Products TDM Performance Verifiers currently in commercial distribution.
1.6 Device description
The VITROS Chemistry Products GENT Reagent. VITROS Chemistry Products Calibrator Kit 13, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS GENT assay. VITROS Chemistry Products GENT Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure gentamicin.
VITROS Chemistry Products Calibrator Kit 13 and TDM Performance Verifiers are packaged and sold separately.
VITROS Chemistry Products Calibrator Kit 13 is a liquid ready to use calibrator set for gentamicin. 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).
Device intended use(s) 1.7
VITROS Chemistry Products GENT Reagent: For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
VITROS Chemistry Products Calibrator Kit 13: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5.1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT).
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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 GENT on VITROS Chemistry Systems.
1.8 Comparison to predicate device: Reagent and Calibrators
The VITROS Chemistry Products GENT Reagent and VITROS Chemistry Products Calibrator Kit 13 and are substantially equivalent to the SYVA Emit 2000 Gentamicin Plus Assay and the SYVA Emit 2000 Gentamicin Plus Calibrators, which were cleared by FDA (K962519) for IVD use.
The relationship between the VITROS GENT assay and the predicate device, determined by least squares linear regression, is:
VITROS GENT assay = 1.00 X - 0.0138 ug/mL, with a correlation coefficient of 0.993, 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 GENT assay (refer to the VITROS Chemistry Products GENT Reagent Instructions for Use for summaries of the results of these studies).
The table below lists the characteristics of the VITROS Chemistry Products GENT assay and the predicate device.
| Device
Characteristic | VITROS GENT Assay
(New device) | SYVA Emit 2000 Gentamicin Plus
Assay (Predicate device) |
|--------------------------|-------------------------------------------|------------------------------------------------------------|
| Intended Use | Quantitative measurement of
gentamicin | Quantitative measurement of
gentamicin |
| Basic principle | Homogeneous enzyme
immunoassay | Homogeneous enzyme immunoassay |
| Reportable
Range | 0.6 - 10 µg/mL | 0.25 - 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 |
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Comparison to predicate device: Performance Verifiers 1.9
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 gentamicin so that the TDM Performance Verifiers may be used with the VITROS Chemistry Products GENT assay.
1.10 Conclusions
The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products GENT reagent, VITROS Chemistry Products Calibrator Kits 13 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.
VITROS Chemistry Products GENT assay and Controls Ortho-Clinical Diagnostics, Inc.
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Image /page/4/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 stripes extending from its head, representing health and human services. 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
JAN - 6 2005
Ms. Carey A. Mayo, M.S., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101
Re: K042479
Trade/Device Name: VITROS Chemistry Products GENT Reagent VITROS Chemistry Products Calibrator Kit 13 VITROS Chemistry Products TDM Performance Verifiers I, II, and III Regulation Number: 21 CFR 862.3450
Regulation Name: Gentamicin test system Regulatory Class: Class II Product Code: LCD, DLJ, DIF Dated: December 7, 2004 Received: December 8, 2004
Dear Ms. Mayo:
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. Iisting 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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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,
Carelia B. Looks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K042479 510(k) Number (if known):
Device Name:
Indications for Use:
-
- VITROS Chemistry Products GENT Reagent
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- VITROS Chemistry Products Calibrator Kit 13
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- VITROS Chemistry Products TDM Performance Verifiers I, II, and III
- For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
-
- For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT).
-
- 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 GENT on VITROS Chemistry Systems.
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. Benson
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k: K042479
VITROS Chemistry Products GENT assay and Controls Ortho-Clinical Diagnostics, Inc.