(75 days)
No
The summary describes a standard automated clinical chemistry analyzer and associated reagents, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No.
The device is for in vitro diagnostic use, specifically to measure caffeine concentration in human serum and plasma, which is used to monitor therapy rather than provide therapy directly.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" for both the VITROS Chemistry Products CAFFN Reagent Kit and the VITROS TDM Performance Verifier. Additionally, the device quantitatively measures caffeine concentration to monitor therapy, which falls under diagnostic purposes.
No
The device description clearly outlines a system comprised of instrumentation (VITROS 5,1 FS Chemistry System), reagent kits, thin film products, and common reagents. This indicates a hardware-based system with associated consumables, 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 both the CAFFN Reagent Kit and the TDM Performance Verifier.
- Measurement in Human Specimens: The intended use is to measure caffeine concentration in "human serum and plasma". This is a key characteristic of IVD devices, which analyze specimens taken from the human body.
- Diagnostic Purpose: The measurement is for "subjects undergoing therapy with caffeine, especially for cases of neonatal apnea." This indicates the test is used to monitor treatment and potentially aid in diagnosis or management of a medical condition.
- Device Description: The description details a "clinical chemistry analyzer" and "chemistry reagents" designed for "in vitro determination of various analytes in human specimens." This aligns with the definition of an IVD system.
N/A
Intended Use / Indications for Use
- For in vitro diagnostic use only. VITROS Chemistry Products CAFFN Reagent Kit is used on the VITROS 5,1 FS Chemistry System to quantitatively measure caffeine (CAFFN) concentration in human serum and plasma of subjects undergoing therapy with caffeine, especially for cases of neonatal apnea.
- 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 CAFFN on VITROS Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
KLS, DIF
Device Description
The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens. The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
-
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
-
- The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products CAFFN Reagent Kit (Reagents 1 and 2, Buffer and Calibrators) and the VITROS Chemistry Products TDM Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS CAFFN assay.
-
- The VITROS Chemistry Products Thin Film range of products, which are dry, multilavered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
-
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 3).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
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
subjects undergoing therapy with caffeine, especially for cases of neonatal apnea.
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)
The relationship between the VITROS CAFFN assay and the predicate device, determined by least squares linear regression, is:
VITROS CAFFN assay = 0.9995 X - 0.04 ug/mL with a correlation coefficient of 0.989, where X is the predicate device.
In addition to the above mentioned correlation study, studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS CAFFN assay, (refer to the VITROS Chemistry Products CAFFN Reagent Kit Instructions for Use for summaries of the results of these studies).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 862.3880 Theophylline test system.
(a)
Identification. A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.(b)
Classification. Class II.
0
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: K042520
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 15, 2004
1.3 Device Proprietary Name(s)
Trade Name(s) VITROS Chemistry Products CAFFN Reagent Kit VITROS Chemistry Products TDM Performance Verifier I, II, and III
Common Name Caffeine assay and controls
1.4 Classification Name(s)
Theophylline Test System: Class II (21 CFR 862.3880) Assayed Controls: Class I, reserved (21 CFR 862.1660)
1.5 Predicate devices
The VITROS Chemistry Products CAFFN assay is substantially equivalent to the SYVA® Emit® Caffeine Assay (Dade Behring, Inc.)
The modified VITROS Chemistry Products TDM Performance Verifiers are substantially equivalent to the VITROS Chemistry Products TDM Performance Verifiers currently in commercial distribution.
1
1.6 Device description
The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens. The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
-
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
-
- The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products CAFFN Reagent Kit (Reagents 1 and 2, Buffer and Calibrators) and the VITROS Chemistry Products TDM Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS CAFFN assay.
-
- The VITROS Chemistry Products Thin Film range of products, which are dry, multilavered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
-
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 3).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
2
Device intended use 1.7
VITROS Chemistry Products CAFFN Reagent Kit: For in vitro diagnostic use only. VITROS Chemistry Products CAFFN Reagent Kit is used on the VITROS 5,1 FS Chemistry System to quantitatively measure caffeine (CAFFN) concentration in human serum and plasma of subjects undergoing therapy with caffeine, especially for cases of neonatal apnea.
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 CAFFN on VITROS Chemistry Systems.
Comparison to predicate device: Reagent Kit 1.8
The VITROS Chemistry Products CAFFN Reagent Kit is substantially equivalent to the SYVA Emit Caffeine Assay, which was cleared by FDA (K853872) for IVD use. For this device, the intended use includes the application of the test in monitoring patients treated with caffeine as a therapeutic agent for neonatal apnea 1.2. Treatment of neonatal apnea with caffeine was approved by the FDA (9/21/99, NDA #020793).
The relationship between the VITROS CAFFN assay and the predicate device, determined by least squares linear regression, is:
VITROS CAFFN assay = 0.9995 X - 0.04 ug/mL with a correlation coefficient of 0.989, where X is the predicate device.
In addition to the above mentioned correlation study, studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS CAFFN assay, (refer to the VITROS Chemistry Products CAFFN Reagent Kit Instructions for Use for summaries of the results of these studies).
3
The table below lists the characteristics of the VITROS Chemistry Products CAFFN Assay and the predicate device.
| Device
Characteristic | VITROS Chemistry
Products CAFFN Assay
(New device #1) | SYVA Emit Caffeine Assay
(Predicate device #1) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Intended Use | Quantitative measurement
of caffeine concentration in
human serum and plasma of
subjects undergoing therapy
with caffeine, especially for
cases of neonatal apnea. | Quantitative measurement of
caffeine as a metabolite. |
| Basic principle | Homogeneous enzyme
immunoassay | Homogeneous enzyme
immunoassay |
| Reportable Range | 1 - 30 µg/mL | 1 - 30 µg/mL |
| Instrumentation | VITROS 5,1 FS Chemistry
System | SYVA-30R Biochemical
System |
| Sample type | Serum and plasma | Serum |
Comparison to predicate device: Performance Verifiers 1.9
The modified 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 currently in commercial distribution (K984288). The only difference is the addition of caffeine to the controls. The labeling will be updated to add assigned values for caffeine so that the TDM Performance Verifiers may be used with the VITROS Chemistry Products CAFFN assay.
1.10 Conclusions
The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products CAFFN assay and the VITROS 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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
NOV 3 0 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carey A. Mayo, MS., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626-5101
Re: K042520
Trade/Device Name: VITROS Chemistry Products CAFFN Reagent Kit VITROS Chemistry Products TDM Performance Verifiers, I, II, and III Regulation Number: 21 CFR 862.3880 Regulation Name: Theophylline test system Regulatory Class: Class II Product Code: KLS, DIF Dated: November 12, 2004 Received: November15, 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Cornelius B. Lotz
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
6
Indications for Use
510(k) Number (if known): K042520
Device Name:
-
- VITROS Chemistry Products CAFFN Reagent Kit
-
- VITROS Chemistry Products TDM Performance Verifiers I, II, and III
Indications For Use:
-
- For in vitro diagnostic use only. VITROS Chemistry Products CAFFN Reagent Kit is used on the VITROS 5,1 FS Chemistry System to quantitatively measure caffeine (CAFFN) concentration in human serum and plasma of subjects undergoing therapy with caffeine, especially for cases of neonatal apnea.
-
- 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 CAFFN on VITROS Chemistry Systems.
Prescription Use (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. Benner
Division Sign-Off
Office of In Vitro Diagnostla Device Evaluation and Safety
510(k) K042520
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