(110 days)
Not Found
No
The device description details a standard enzyme immunoassay technique. There is no mention of AI, ML, or any computational methods that would suggest the use of these technologies in the analysis or interpretation of results. The performance studies focus on traditional analytical validation methods.
No.
The device is an in vitro diagnostic device used to detect fentanyl in human urine, providing a preliminary analytical test result. It does not directly treat or diagnose a disease or condition.
Yes
The text explicitly states: "This in vitro diagnostic device is for prescription use only."
No
The device description clearly states it is a homogeneous enzyme immunoassay technique and consists of reagents (R1 and R2). This indicates a chemical assay requiring physical components and laboratory equipment, 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 clearly states: "This in vitro diagnostic device is for prescription use only."
- Intended Use: The device is intended for the qualitative detection of fentanyl in human urine, which is a biological specimen. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laboratory-based immunoassay technique used to analyze a specific compound in human urine. This is a typical method used in IVD devices.
- Intended User / Care Setting: The device is intended for use in "laboratories with automated clinical chemistry analyzers," which are common settings for performing in vitro diagnostic tests.
The information provided strongly indicates that the ARK Fentanyl Assay is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ARK Fentanyl Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
The ARK Fentanyl Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
The ARK Fentanyl Assay is a homogeneous enzyme immunoassay technique used for the analysis of a specific compound in human urine. The assay is based on competition between drug in the specimen and drug labeled with recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Fentanyl Assay consists of reagents R1 anti-fentanyl polyclonal antibody with substrate and R2 fentanyl derivative labeled with bacterial recombinant G6PDH enzyme.
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
laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for 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)
Precision studies were performed using CLSI EP05-A3 as a guideline. Drug-free, negative human urine was supplemented with fentanyl (0.00 to 2.00 ng/mL). Each level was assayed in quadruplicate twice a day for 20 days (N=160).
Analytical Specificity: Cross-reactivity of fentanyl metabolites and structural analogs, as well as structurally unrelated compounds and endogenous substances, was evaluated by spiking them into drug-free, negative human urine. Interference from specific gravity and pH was also assessed.
Method Comparison: A total of one hundred fifty (150) unaltered clinical urine specimens were analyzed for fentanyl with the ARK Fentanyl Assay and by LC-MS/MS. Specimens were tested on a Beckman Coulter AU680 analyzer in single replicates and compared to LC-MS/MS results.
Key Results:
Precision: At the 1.0 ng/mL cutoff, 97 negative and 63 positive results were obtained out of 160. Samples at 0.75 ng/mL and below were 100% negative, while samples at 1.25 ng/mL and above were 100% positive.
Analytical Specificity: Norfentanyl showed 10% cross-reactivity at 2.5 ng/mL. Other fentanyl analogs showed varying cross-reactivity percentages (e.g., Acetyl fentanyl 83.33%, Furanyl fentanyl 57.14%, Carfentanil 0.20%). Opioids and structurally similar compounds were negative at tested concentrations. Structurally unrelated compounds and endogenous substances (e.g., Acetaminophen, Ibuprofen, Bilirubin, Creatinine) did not yield false results when spiked into fentanyl-positive/negative urine samples. Specific gravity (1.001 to 1.030) and pH (3.0 to 11.0) also showed no interference. Boric acid (1% w/v) did not interfere.
Method Comparison:
- Low Negative ( 1.5 ng/mL by LC-MS/MS): 0 negative, 64 positive by ARK Assay.
One discordant sample (Sample ID #052) was positive by ARK Immunoassay (LC-MS/MS 0.4 ng/mL), with Norfentanyl detected contributing to the positive result.
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 6, 2018
ARK Diagnostics, Inc. Cherry Mun Manager, Quality and Regulatory Affairs 48089 Fremont Boulevard Fremont, CA 94538
Re: K180427
Trade/Device Name: ARK Fentanyl Assay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: May 3, 2018 Received: May 4, 2018
Dear Cherry Mun:
We have reviewed vour 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. 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
803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180427
Device Name ARK Fentanyl Assay
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
The ARK Fentanyl Assay is an immunoasay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
The ARK Fentanyl Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the prelininary test result is positive.
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 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
510(k) SUMMARY
This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is K180427.
| 807.92 (a)(1): Name: | ARK Diagnostics, Inc. |
|---|---|
| Address: | 48089 Fremont Blvd |
| Fremont, CA 94538 USA | |
| Owner Operator Number: | 10027663 |
| Establishment Registration: | 3005755244 |
| Phone: | (510) 270-6270 |
| FAX: | (510) 270-6298 |
| Contact: | Cherry Mun – (510) 270-6288 |
| Manager of Quality and Regulatory Affairs |
Date Prepared: May 03, 2018
807.92 (a)(2): Device Name – Trade Name, Common Name, and Classification
| Trade Name: | ARK™ Fentanyl Assay |
|---|---|
| Common Name: | Homogeneous Enzyme Immunoassay, Opiate Test System |
Classification:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| DJG | Class II | 21 CFR 862.3650 | |
| Opiate Test System | Toxicology | ||
| (91) |
807.92 (a)(3): Identification of the Legally Marketed Predicate Device
Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay K161216
4
807.92 (a)(4): Device Description
The ARK Fentanyl Assay is a homogeneous enzyme immunoassay technique used for the analysis of a specific compound in human urine. The assay is based on competition between drug in the specimen and drug labeled with recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Fentanyl Assay consists of reagents R1 anti-fentanyl polyclonal antibody with substrate and R2 fentanyl derivative labeled with bacterial recombinant G6PDH enzyme.
807.92 (a)(5): Intended Use / Indications for Use
ARK Fentanyl Assay
The ARK Fentanyl Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
The ARK Fentanyl Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.
5
807.92 (a)(6): Technological Similarities and Differences to the Predicate
SUBSTANTIAL EQUIVALENCE COMPARATIVE TABLE
Comparison between the Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay and the ARK™ Fentanyl Assay
| Characteristic | Predicate Device
Immunalysis SEFRIA™ Fentanyl Urine
Enzyme Immunoassay (K161216) | Candidate Device
ARK™ Fentanyl Assay |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Similarities | | |
| Test System | Homogenous enzyme immunoassay
(EIA) | Same |
| Intended Use | For the qualitative determination of
fentanyl in human urine at a cutoff
concentration of 1.0 ng/mL. | Same |
| Sample Matrix | Human urine | Same |
| User Environment | Clinical laboratories; Prescription use
only | Same |
| Mass Spectrometry
Confirmation | Required to confirm preliminary positive
analytical results | Same |
| Platform Required | Automated clinical chemistry analyzer | Same |
| Reagents Form | Liquid - Ready to use | Same |
| Reagent Materials | Two (2) reagent system:
Antibody/substrate reagent and enzyme
labeled conjugate
Sodium azide preservative | Same |
| Storage | 2-8°C until expiration date | Same |
| Measured Analyte | Fentanyl | Same |
| Antibody | Rabbit antibodies to fentanyl | Same |
| Cutoff Level | 1.0 ng/mL | Same |
| Characteristic | Predicate Device
Immunalysis SEFRIA™ Fentanyl Urine
Enzyme Immunoassay (K161216) | Candidate Device
ARK™ Fentanyl Assay |
|----------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Differences | | |
| Detection | Absorbance change measured
spectrophotometrically at 570 nm. | Absorbance change measured
spectrophotometrically at 340 nm. |
6
807.92 (b)(1) and 807.92 (b)(2): Brief Description of Nonclinical and Clinical Data
The following performance characteristics were obtained on the Beckman Coulter AU680® automated clinical chemistry analyzer.
Precision
Precision studies were performed using CLSI EP05-A3 as a guideline. Drug-free, negative human urine was supplemented with fentanyl (0.00 to 2.00 ng/mL). Each level was assayed in quadruplicate twice a day for 20 days (N=160). Results are summarized in the table below.
| Human Urine
(ng/mL) | Relative %
Cutoff | # of Results | Results |
|------------------------|----------------------|--------------|-----------------------------|
| 0.00 | -100 | 160 | 160 Negative |
| 0.25 | -75 | 160 | 160 Negative |
| 0.50 | -50 | 160 | 160 Negative |
| 0.75 | -25 | 160 | 160 Negative |
| 1.00 | Cutoff | 160 | 97 Negative;
63 Positive |
| 1.25 | +25 | 160 | 160 Positive |
| 1.50 | +50 | 160 | 160 Positive |
| 1.75 | +75 | 160 | 160 Positive |
| 2.00 | +100 | 160 | 160 Positive |
Analytical Specificity
All compounds tested were added to drug-free, negative human urine.
The cross-reactivity of the following metabolites and structural analogs of fentanyl was evaluated by spiking these compounds into drug-free, negative human urine to determine the minimum concentration that would give a positive result approximately equivalent to the 1.0 ng/mL fentanyl cutoff. These concentrations were used to determine the percent cross-reactivity according to the formula:
% Cross-reactivity = (Cutoff concentration / Lowest concentration of cross-reactant causing a positive result) X 100
For the compounds Alfentanil and Remifentanil that did not produce a positive result, the highest concentration tested was used to calculate percent cross-reactivity.
7
Cross-reactivity
Norfentanyl (Major Metabolite)
| Compound | Concentration
Tested
(ng/mL) | Percent Cross-
reactivity (%) |
|-----------------------------------|------------------------------------|----------------------------------|
| Norfentanyl
(Major Metabolite) | 2.5 | 10 |
| | 300 | 0.33 |
Other Metabolites and Structural Analogs of Fentanyl
| Compound | Lowest
Concentration
Tested That
Produced a
Response
Approximately
Equivalent to the
Cutoff
(ng/mL) | Percent Cross-
reactivity (%) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Acetyl fentanyl | 1.20 | 83.33 |
| Acrylfentanyl | 1.20 | 83.33 |
| ω-1-Hydroxyfentanyl | 1.20 | 83.33 |
| Isobutyryl fentanyl | 1.50 | 66.67 |
| Ocfentanil | 1.50 | 66.67 |
| Butyryl fentanyl | 1.60 | 62.50 |
| Furanyl fentanyl | 1.75 | 57.14 |
| Valeryl fentanyl | 2.50 | 40.00 |
| (±) β-
hydroxythiofentanyl | 2.80 | 35.71 |
| 4-Fluoro-isobutyryl
fentanyl | 3.00 | 33.33 |
| Para-fluorobutyryl
fentanyl (p-FBF) | 3.00 | 33.33 |
| Para-fluoro fentanyl | 3.00 | 33.33 |
| (±)-3-cis-methyl
fentanyl | 5.00 | 20.00 |
| Despropionyl
fentanyl (4-ANPP) | 75.00 | 1.33 |
| Carfentanil | 500 | 0.20 |
| Sufentanil | 625 | 0.16 |
| Norcarfentanil | 5,000 | 10.0 ng/mL) were diluted with negative urine calibrator (ARK Fentanyl Calibrator A) and retested.
Results are summarized as follows:
| ARK Result | Low Negative
Less than
50% below
the Cutoff | Near Cutoff
Negative
Between 50%
below the
Cutoff and the
Cutoff | Near Cutoff
Positive
Between the
Cutoff and
50% above
the Cutoff | High Positive
Greater than
50% above
the Cutoff |
|------------|------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------|
| | ( 1.5 ng/mL
by LC-
MS/MS) |
| Positive | 1* | 20 | 12 | 64 |
| Negative | 50 | 3 | 0 | 0 |
Discordant Results
*Norfentanyl was detected in this discordant sample (Sample ID #052) and contributed to the positive result obtained with the ARK Fentanyl Assay for this sample.
| Sample ID Number | ARK Immunoassay Result | Fentanyl
(ng/mL by LC-MS/MS) |
|------------------|------------------------|---------------------------------|
| 051 | Positive | 0.7 |
| 052* | Positive | 0.4 |
| 053 | Positive | 0.9 |
| 054 | Positive | 0.9 |
| 055 | Positive | 0.6 |
| 056 | Positive | 0.6 |
| 057 | Positive | 0.9 |
| 058 | Positive | 0.5 |
| 059 | Positive | 0.9 |
| 060 | Positive | 0.5 |
| 061 | Positive | 0.9 |
| 062 | Positive | 0.6 |
| 063 | Positive | 0.9 |
12
| Sample ID Number | ARK Immunoassay Result | Fentanyl
(ng/mL by LC-MS/MS) |
|------------------|------------------------|---------------------------------|
| 064 | Positive | 0.8 |
| 065 | Positive | 0.5 |
| 066 | Positive | 0.7 |
| 069 | Positive | 0.5 |
| 070 | Positive | 0.6 |
| 072 | Positive | 0.6 |
| 073 | Positive | 0.8 |
| 074 | Positive | 0.6 |
Traceability and Value Assignment
ARK Fentanyl Calibrators and Controls are prepared by volumetric dilution of high purity fentanyl (certified solution traceable to HPLC) into non-sterile, processed human urine free of fentanyl. Testing is performed with the ARK Fentanyl Assay on the Beckman Coulter AU680 automated clinical chemistry analyzer, calibrated with the ARK Fentanyl Calibrator.
Calibration Curve Stability
A stored calibration curve was effective up to at least 15 days based on supporting data. Calibration curve stability may depend on individual laboratory performance.
807.92 (b)(3): Conclusions from Nonclinical Testing
As summarized above, the ARK Fentanyl Assay is substantially equivalent to the legally marketed predicate device, Immunalysis SEFRIA™ Fentany] Urine Enzyme Immunoassay (K161216).