(492 days)
Not Found
No
The description details a standard immunoassay system with automated processing and signal detection. There is no mention of AI or ML being used for data analysis, interpretation, or result generation beyond simple comparison to a cut-off value.
No.
The device is for in vitro diagnostic use, intended for the qualitative determination of parent drug molecules and their metabolites in human urine. It provides analytical test results and does not directly provide therapy.
Yes
The document explicitly states, "For in vitro diagnostic use only" and "The assays are diagnostic tests for qualitative determination of the parent molecule and metabolites of drugs in human urine."
No
The device description clearly states it is a "benchtop fully automated Biochip Array System" and includes hardware components like a CCD camera and a self-contained biochip cartridge. While it uses software, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For in vitro diagnostic use only."
- Intended Use: The intended use is the "qualitative determination of parent drug molecule and metabolites of drugs in human urine." This involves testing a sample taken from the human body outside of the body to diagnose or provide information about a physiological state.
- Device Description: The device description details a system that performs "simultaneous detection of multiple analytes from a single sample" using a "competitive chemiluminescent immunoassay" on a "solid-state device containing an array of discrete test regions containing immobilized antibodies." This is a typical description of an in vitro diagnostic test system.
- Sample Type: The device analyzes "human urine," which is a biological sample taken from the body.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cutoffs.
The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut-offs:
| Analyte | Analyte in Cut Off Material | Cut-Off |
|---|---|---|
| Phenobarbital | Phenobarbital | 200 ng/ml |
| Tramadol | Tramadol | 200 ng/ml |
| Phencyclidine | Phencyclidine | 25 ng/ml |
| Buprenorphine | Norbuprenorphine | 5 ng/ml |
| 6-Acetylmorphine | 6-Acetylmorphine | 10 ng/ml |
The Evidence MultiSTAT DOA Urine MultiPlex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DIS, LCM
Device Description
The Evidence MultiSTAT analyzer is a benchtop fully automated Biochip Array System. It performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilized antibodies specific to different Drugs of Abuse (DOA) compound classes. A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT system which, together with the analyzer software, is used to quantify the light output and produce meaningful results.
The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted.
Evidence MultiSTAT assays employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output.
The Evidence MultiSTAT DOA Urine MultiPlex uses Randox Biochip Technology and performs simultaneous detection of multiple analytes from a single sample, using the Evidence MultiSTAT analyzer. The assays are diagnostic tests for qualitative determination of the parent molecule and metabolites of drugs in human urine. The qualitative tests are based on a cut off value for each analyte, as detailed in the table below.
The Evidence MultiSTAT DOA Urine MultiPlex (EV4393) will be supplied as a test kit comprising:
- 12 x Urine Test Cartridges
- 6 x 1 ml Urine Cut Off Material (lyophilized)
- 4 x 1 ml Urine Positive Control Material (lyophilized)
- 2 x 10 ml Reconstitution Buffer
- 1 x USB which contains batch specific update and Instructions for Use (IFU)
- 1 x Batch Barcodes
Each kit is supplied with the Evidence MultiSTAT Accessory kit (EV4116) which contains:
- 12 x MultiSTAT Tip Cartridges
- 1 x Tip/Waste Cartridge
- 6 x 1000 ul Pipette Tip
Reagent Composition:
MultiSTAT DOA Urine MultiPlex Assay Diluent: 20 mM phosphate buffer, pH 7.0 containing protein, detergents, and preservatives. This is contained within the cartridge.
MultiSTAT DOA Urine MultiPlex Conjugate: 20 mM Tris based buffer, pH 7.0 containing protein, preservatives, and horseradish peroxidase - labelled drug derivatives. This is contained within the cartridge.
MultiSTAT DOA Urine MultiPlex Biochip: Solid substrate containing immobilized antibody discrete test regions. This is contained within the cartridge.
MultiSTAT DOA Urine MultiPlex Wash Buffer: 20 mM Tris buffered saline, pH 7.4, containing surfactant and preservatives. This is contained within the cartridge.
LUM-EV934/PX: Luminol-EV934 and Peroxide are contained within the cartridge and are mixed in a ratio of 1:1 by the analyser to give the working signal reagent
MultiSTAT DOA Urine MultiPlex Cut Off: Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives and drug concentrations at the assay cut off values (detailed in Table 5 above).
MultiSTAT DOA Urine MultiPlex Positive Control: Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives, and drug concentrations.
MultiSTAT Reconstitution Buffer: A solution at a neutral pH containing preservatives.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use Only
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 evaluate performance with regards to the precision, specificity, and accuracy of the candidate devices.
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.
MEDTOXScan® Reader (K091454)
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.
Not Found
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
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Randox Laboratories Limited Karena Shaw Regulatory Affairs Manager 55 Diamond Road Crumlin, Co. Antrim BT29 40Y United Kingdom
Re: K221550
Trade/Device Name: Evidence MultiSTAT DOA Urine MultiPlex Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DIS, LCM Dated: March 8, 2023 Received: April 14, 2023
Dear Karena Shaw:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Joseph A. Digitally signed by
Joseph A. Joseph A. Kotarek -S Kotarek -S Date: 2023.10.05
Joseph Kotarek Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221550
Device Name Evidence MultiSTAT Urine DOA MultiPlex
Indications for Use (Describe)
The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cutoffs.
The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut-offs:
| Analyte | Analyte in Cut Off Material | Cut-Off |
|---|---|---|
| Phenobarbital | Phenobarbital | 200 ng/ml |
| Tramadol | Tramadol | 200 ng/ml |
| Phencyclidine | Phencyclidine | 25 ng/ml |
| Buprenorphine | Norbuprenorphine | 5 ng/ml |
| 6-Acetylmorphine | 6-Acetylmorphine | 10 ng/ml |
The Evidence MultiSTAT DOA Urine MultiPlex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
For in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
1. Substantial Equivalence as required by 21 CFR 807.92 Statement
This summary of the 510(k) substantial equivalence information is being submitted in accordance with the requirement of 21 CFR 807.92.
2. 510(k) Number Owner's Name and Address
| Name: | Randox Laboratories Limited |
|---|---|
| Address: | 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, |
| United Kingdom | |
| Telephone: | +44 2894422413 |
| Contact Person: | Karena Shaw |
| E-mail: | Karena.Shaw@randox.com |
Date of Summary Preparation: 04 October 2023
3. Device Proprietary Names, Common Names, Purpose for Submission, Classification Name, Panel, Product Code and 21 CFR Number
| 510(k) Number: | K221550 |
|---|---|
| Device Proprietary Names: | Evidence MultiSTAT DOA Urine MultiPlex |
| Common Names: | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
Classification Names:
The Candidate Device Test System Regulatory Classification is Class II; the Classification Panel is Clinical Chemistry (75) and Clinical Toxicology (91). Regulatory information for the test system is detailed in table 1.
| Product Code | Classification Name | Classification | Regulation Section | Panel |
|---|---|---|---|---|
| DIS | Barbiturate Test System | II | 21 CFR 862.3150 | Clinical |
| Toxicology | ||||
| (91) | ||||
| DJG | Opiate Test System | II | 21 CFR 862.3650 | Clinical |
| Toxicology | ||||
| (91) | ||||
| LCM | Phencyclidine Test System | Clinical | ||
| Toxicology | ||||
| (91) |
Table 1
4. Predicate Device Proprietary Names and 510(k) Numbers
The predicate device for the Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT is the MEDTOXScan® Reader (K091454).
4
| Item | Candidate Device
(K221550)
Evidence MultiSTAT
Urine DOA MultiPlex | Predicate Device
(K091454)
MEDTOXScan Reader |
|----------------------|----------------------------------------------------------------------------|----------------------------------------------------|
| Indications for Use | Qualitative detection of
drugs of abuse in urine | Same |
| Intended Use Setting | Prescription Use Only | Same |
| Methodology | Qualitative,
Competitive
Immunoassay | Qualitative
immunochromatographic |
| Analytes | Phenobarbital,
Phencyclidine | Same |
| Cutoffs (ng/mL) | Phenobarbital (200)
Phencyclidine (25) | Same |
Table 2: Similarities and Differences to Predicate Device
4.1 The Evidence MultiSTAT analyzer is a benchtop fully automated Biochip Array System. It performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilized antibodies specific to different Drugs of Abuse (DOA) compound classes. A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT system which, together with the analyzer software, is used to quantify the light output and produce meaningful results.
The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted.
Evidence MultiSTAT assays employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output.
4.2 The Evidence MultiSTAT DOA Urine MultiPlex uses Randox Biochip Technology and performs simultaneous detection of multiple analytes from a single sample, using the Evidence MultiSTAT analyzer. The assays are diagnostic tests for qualitative determination of the parent molecule and metabolites of drugs in human urine. The qualitative tests are based on a cut off value for each analyte, as detailed in the table below.
Table 3: Analytes, Associated Analyte in the Cut Off Material and Cut Off concentration employed in the Evidence MultiSTAT DOA Urine MultiPlex
| Analyte | Analyte in Cut Off Material | Cut Off |
|---|---|---|
| Phenobarbital | Phenobarbital | 200 ng/ml |
| Tramadol | Tramadol | 200 ng/ml |
| Phencyclidine | Phencyclidine | 25 ng/ml |
5
| Buprenorphine | Norbuprenorphine | 5 ng/ml |
|---|---|---|
| 6-Acetylmorphine | 6-Acetylmorphine | 10 ng/ml |
6
The Evidence MultiSTAT DOA Urine MultiPlex (EV4393) will be supplied as a test kit comprising:
- । 12 x Urine Test Cartridges
- 6 x 1 ml Urine Cut Off Material (lyophilized) -
- 4 x 1 ml Urine Positive Control Material (lyophilized)
- 2 x 10 ml Reconstitution Buffer -
- 1 x USB which contains batch specific update and Instructions for Use (IFU) -
- । 1 x Batch Barcodes
Each kit is supplied with the Evidence MultiSTAT Accessory kit (EV4116) which contains:
- 12 x MultiSTAT Tip Cartridges
- o 1 x Tip/Waste Cartridge
- 6 x 1000 ul Pipette Tip o
- o
Reagent Composition
MultiSTAT DOA Urine MultiPlex Assay Diluent
20 mM phosphate buffer, pH 7.0 containing protein, detergents, and preservatives. This is contained within the cartridge.
MultiSTAT DOA Urine MultiPlex Conjugate
20 mM Tris based buffer, pH 7.0 containing protein, preservatives, and horseradish peroxidase - labelled drug derivatives. This is contained within the cartridge.
MultiSTAT DOA Urine MultiPlex Biochip
Solid substrate containing immobilized antibody discrete test regions. This is contained within the cartridge.
MultiSTAT DOA Urine MultiPlex Wash Buffer
20 mM Tris buffered saline, pH 7.4, containing surfactant and preservatives. This is contained within the cartridge.
LUM-EV934/PX
Luminol-EV934 and Peroxide are contained within the cartridge and are mixed in a ratio of 1:1 by the analyser to give the working signal reagent
MultiSTAT DOA Urine MultiPlex Cut Off
Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives and drug concentrations at the assay cut off values (detailed in Table 5 above).
MultiSTAT DOA Urine MultiPlex Positive Control
Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives, and drug concentrations.
MultiSTAT Reconstitution Buffer A solution at a neutral pH containing preservatives.
7
5. Intended Use
The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cutoffs.
The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut-offs:
| Analyte | Analyte in Cut Off Material | Cut-Off |
|---|---|---|
| Phenobarbital | Phenobarbital | 200 ng/ml |
| Tramadol | Tramadol | 200 ng/ml |
| Phencyclidine | Phencyclidine | 25 ng/ml |
| Buprenorphine | Norbuprenorphine | 5 ng/ml |
| 6-Acetylmorphine | 6-Acetylmorphine | 10 ng/ml |
The Evidence MultiSTAT DOA Urine MultiPlex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
For in vitro diagnostic use only.
6. Performance
Studies were performed to evaluate performance with regards to the precision, specificity, and accuracy of the candidate devices.
7. Conclusions
Based on the information provided in this 510(k), the Evidence MultiSTAT DOA Urine MultiPlex and associated assays are substantially equivalent to the predicate devices and raises no new issues of safety and effectiveness.