(79 days)
No
The document describes a standard in vitro diagnostic assay for measuring valproic acid 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
The device is an in vitro diagnostic product designed to measure valproic acid levels in human serum and plasma for diagnostic and monitoring purposes, not for direct therapeutic intervention.
Yes
The intended use explicitly states "Serum or plasma valproic acid measurements are used in the diagnosis and treatment of valproic acid 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 component is essential to the device's function.
Based on the provided text, the 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" multiple times for the reagent, calibrator, and performance verifier.
- Purpose: The device is used to "quantitatively measure valproic acid (VALP) concentration in human serum and plasma," which is a diagnostic test performed outside of the body (in vitro).
- Clinical Use: The results are used "in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy," which are clear diagnostic and therapeutic monitoring applications.
- Components: The description details reagents, calibrators, and controls, which are typical components of an in vitro diagnostic assay system.
N/A
Intended Use / Indications for Use
- For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma. Serum or plasma valproic acid measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
- For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 12 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of valproic acid (VALP).
- 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 VALP on VITROS Chemistry Systems.
Product codes
LEG, DLJ, DIF
Device Description
The VITROS Chemistry Products VALP Reagent, VITROS Chemistry Products Calibrator Kit 12, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS VALP assay. VITROS Chemistry Products VALP Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure valproic acid.
VITROS Chemistry Products Calibrator Kit 12 and TDM Performance Verifiers are packaged and sold separately.
VITROS Chemistry Products Calibrator Kit 12 is a liquid ready to use calibrator set for valproic acid. 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 assaved 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 (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 VALP assay (refer to the VITROS Chemistry Products VALP Reagent Instructions for Use for summaries of the results of these studies). The relationship between the VITROS VALP assay and the predicate device, determined by least squares linear regression, is: VITROS VALP assay = 0.969 X + 1.339 ug/mL, with a correlation coefficient of 0.992, where X is the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SYVA® Emit® 2000 Valproic Acid Assay, SYVA® Emit® 2000 Valproic Acid Calibrators (Dade Behring, Inc.), K984288
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.
0
DEC - 1 2004
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: K042476
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 VALP Reagent VITROS Chemistry Products Calibrator Kit 12 VITROS Chemistry Products TDM Performance Verifier I, II, and III
Common Name Valproic acid assay and controls
1.4 Classification Name(s)
There is no classification regulation for valproic acid. The product code is LEG. Calibrators: Class II (21 CFR 862.3200) Assayed Controls: Class I (21 CFR 862. 3280)
1.5 Predicate device
The VITROS Chemistry Products VALP Reagent and Calibrator Kit 12 are substantially equivalent to the SYVA® Emit® 2000 Valproic Acid Assay and the SYVA® Emit® 2000 Valproic Acid Calibrators (Dade Behring, Inc.) The VITROS Chemistry Products TDM Performance Verifiers are substantially equivalent to the VITROS Chemistry Products TDM Performance Verifiers currently in commercial distribution.
1
Device description 1.6
The VITROS Chemistry Products VALP Reagent, VITROS Chemistry Products Calibrator Kit 12, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS VALP assay. VITROS Chemistry Products VALP Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure valproic acid.
VITROS Chemistry Products Calibrator Kit 12 and TDM Performance Verifiers are packaged and sold separately.
VITROS Chemistry Products Calibrator Kit 12 is a liquid ready to use calibrator set for valproic acid. 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 assaved 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
VITROS Chemistry Products VALP Reagent: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma. Serum or plasma valproic acid measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
VITROS Chemistry Products Calibrator Kit 12: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 12 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of valproic acid (VALP).
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 VALP on VITROS Chemistry Systems.
2
Comparison to predicate device: Reagent and Calibrators 1.8
The VITROS Chemistry Products VALP Reagent and VITROS Chemistry Products Calibrator Kit 12 and are substantially equivalent to the SYVA Emit 2000 Valproic Acid Assay and the SYVA Emit 2000 Valproic Acid Calibrators, which were cleared by FDA (K002551) for IVD use.
The relationship between the VITROS VALP assay and the predicate device, determined by least squares linear regression, is:
VITROS VALP assay = 0.969 X + 1.339 ug/mL, with a correlation coefficient of 0.992, 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 VALP assay, (refer to the VITROS Chemistry Products VALP Reagent Instructions for Use for summaries of the results of these studies).
| Device
Characteristic | VITROS Chemistry
Products VALP Assay
(New device #1) | SYVA Emit 2000 Valproic
Acid Assay
(Predicate device #1) |
|--------------------------|------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use | Quantitative measurement
of valproic acid | Same |
| Basic principle | Homogeneous enzyme
immunoassay | Same |
| Reportable Range | 10 – 150 µg/mL | 1 - 150 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 |
The table below lists the characteristics of the VITROS Chemistry Products VALP Assay and the predicate device.
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 currently in commercial distribution (K984288). The only difference is the addition of one constituent to the controls. The labeling will be updated to add assigned values for valproic acid so that the TDM Performance Verifiers may be used with the VITROS Chemistry Products VALP assay.
3
1.10 Conclusions
The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products VALP 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 a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized symbol that resembles a person embracing another person. The symbol is composed of several curved lines that create the shape of two figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 1 2004
Ms. Carey A. Mayo, M.S., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
K042476 Re: Trade/Device Name: VITROS Chemistry Products VALP Reagent VITROS Chemistry Products Calibrator Kit 12 VITROS Chemistry TDM Performance Verifiers I, II, and III Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: LEG, DLJ, DIF Dated: November 10, 2004 Received: November 12, 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 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) This letter will and in your to one finding of substantial equivalence of your device to a legally premated 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 you don't epother monotion 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,
Cornelia 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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2.0 Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known): | K042476 | |
|---|---|---|
| Device Name: | 1. VITROS Chemistry Products VALP Reagent |
- VITROS Chemistry Products Calibrator Kit 12
- VITROS Chemistry Products TDM Performance Verifiers I, II, and III | |
| Indications for Use: | 1. For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma. Serum or plasma valproic acid measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy. - For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 12 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of valproic acid (VALP).
- 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 VALP 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)
A2ke
Divisio Sign-Off
Office of In Vitro Diagnostic Device I valuation and
510(k. K042476
Ortho-Clinical Diagnostics, Inc.