(268 days)
Not Found
No
The description details a standard enzyme immunoassay for detecting oxycodone in urine. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis is based on chemical reactions and optical density measurements, not algorithmic learning.
No
This device is an in-vitro diagnostic assay used for the qualitative and semi-quantitative analysis of Oxycodone in human urine; it does not treat or prevent any disease or condition.
Yes
Explanation: The device is intended for the qualitative and semi-quantitative analysis of Oxycodone in human urine to provide a "preliminary analytical test result," which is a form of diagnosis in the context of drug testing. Although a confirmatory method is recommended, the initial analysis contributes to a diagnostic process.
No
The device is an in-vitro diagnostic assay kit consisting of chemical reagents (antibody/substrate reagent, enzyme conjugate reagent) and associated calibrators and controls. It is intended for use with automated clinical chemistry analyzers, which are hardware devices. The description focuses on the chemical components and their function in the assay, not on software performing a medical function.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This in-vitro device is for prescription use only."
- Nature of the Test: The device is an "enzyme immunoassay" intended for the "qualitative and semi-quantitative analysis of Oxycodone in human urine." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a patient's condition (presence of oxycodone).
- Components: The device description details reagents, calibrators, and controls, which are typical components of an IVD kit used in a laboratory setting.
- Intended Use Setting: The intended use is "for use in laboratories," which is a common setting for IVD testing.
Therefore, the device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunalysis Oxycodone Urine Enzyme Immunoassay:
The Immunalysis Oxycodone Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 100ng/mL and 300ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Oxycodone in human urine with automated clinical chemistry analyzers. This assay is calibrated against Oxycodone. This in-vitro device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Oxycodone Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Immunalysis Oxycodone Urine Controls:
The Immunalysis Oxycodone Urine Controls are used as control materials in the Immunalysis Oxycodone Urine Enzyme Immunoassay.
Immunalysis Oxycodone Urine Calibrators:
The Immunalysis Oxycodone Urine Calibrators are used as calibrators in the Immunalysis Oxycodone Urine Enzyme Immunoassay for the qualitative and semiquantitative determination of Oxycodone in urine on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DLJ, LAS
Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes recombinant monoclonal antibodies to Oxycodone, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes oxycodone derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The oxycodone calibrator and controls consists of a single calibrator at 100ng/mL or 300ng/mL, a control set containing a LOW control (75ng/mL or 225ng/mL) and a HIGH control (125ng/mL or 375ng/mL) and a calibrator set containing a negative calibrator, a Level 1 calibrator at 100ng/mL, a Level 2 calibrator at 300ng/mL, a Level 3 calibrator at 500ng/mL and a Level 4 calibrator at 1000ng/mL.
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
laboratories
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 following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Oxycodone Urine Enzyme Immunoassay to the predicate
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- Precision/ Cutoff Characterization
-
- Specificity and Cross-Reactivity
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- Interference
-
- Linearity/ Recovery
- Method Comparison 5.
-
- Stability
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
510(k) SUMMARY
JAN 17 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
- A. Contact Information 1. Manufacturer: Immunalysis Corporation 2. Contact Name: Joseph Ginete 3. Contact Title: Regulatory Affairs Specialist 829 Towne Center Drive Pomona, CA 91767 4. Address: (909) 482-0840 5. Phone: (909) 482-0850 6. Fax: 7. Email: iginete@immunalysis.com December 20, 2013 8. Summary prepared on: B. Device Information 1. Trade Name: Immunalysis Oxycodone Urine Enzyme Immunoassay Immunalysis Oxycodone Urine Controls Immunalysis Oxycodone Urine Calibrators Immunalysis Oxycodone Urine Enzyme Immunoassay 2. Common Name: Immunalysis Oxvcodone Urine Controls Immunalysis Oxycodone Urine Calibrators 3. Device Classification: ============================================================================================================================================================================== Requlation Number: CFR 862.3650 Opiate Test System 4. CFR 862.3200 Clinical Toxicology Calibrator CFR 862.3280 Clinical Toxicology Control Materials 5. Panel: Toxicology(91) 6. Product Code: DJG DLJ LAS C. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3)) DRI Oxycodone Assay 1. Predicate Device:
DRI Oxycodone Controls
DRI Oxycodone Calibrators Microgenics 2. Predicate Company: K040411 3. Predicate K Number:
IMMUNALYSIS
1
İMMUNALYSIS
D. Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes recombinant monoclonal antibodies to Oxycodone, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes oxycodone derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The oxycodone calibrator and controls consists of a single calibrator at 100ng/mL or 300ng/mL, a control set containing a LOW control (75ng/mL or 225ng/mL) and a HIGH control (125ng/mL or 375ng/mL) and a calibrator set containing a negative calibrator, a Level 1 calibrator at 100ng/mL, a Level 2 calibrator at 300ng/mL, a Level 3 calibrator at 500ng/mL and a Level 4 calibrator at 1000ng/mL.
E. Intended Use
Immunalysis Oxycodone Urine Enzyme Immunoassay:
The Immunalysis Oxycodone Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 100ng/mL and 300ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Oxycodone in human urine with automated clinical chemistry analyzers. This assay is calibrated aqainst Oxycodone. This in-vitro device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Oxycodone Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Immunalysis Oxycodone Urine Controls:
The Immunalysis Oxycodone Urine Controls are used as control materials in the Immunalysis Oxycodone Urine Enzyme Immunoassay.
Immunalysis Oxycodone Urine Calibrators:
The Immunalysis Oxycodone Urine Calibrators are used as calibrators in the Immunalysis Oxycodone Urine Enzyme Immunoassay for the qualitative and semiquantitative determination of Oxycodone in urine on automated clinical chemistry analyzers.
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IMMUNALYSIS
- F. Comparison of the new device with the predicate device
| Item | Predicate Device (K040411) | Test Device |
|---|---|---|
| Type of Product | Analytical Reagents | Analytical Reagents |
| Measured Analytes | Oxycodone | Oxycodone |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 100ng/mL and 300ng/mL of | |
| Oxycodone | 100ng/mL and 300ng/mL of | |
| Oxycodone | ||
| Test System | Homogenous Enzyme | |
| Immunoassay | Homogenous Enzyme | |
| Immunoassay | ||
| Materials | Antibody/ Substrate Reagents and | |
| Enzyme Labeled Conjugate | Antibody/ Substrate Reagents and | |
| Enzyme Labeled Conjugate | ||
| Mass Spectroscopy | ||
| Confirmation | Required for preliminary positive | |
| analytical results | Required for preliminary positive | |
| analytical results | ||
| Antibody | Mouse monoclonal anti-oxycodone | |
| derivative | Recombinant FAB Antibody to | |
| Oxycodone | ||
| Storage | 2 - 8°C until expiration date | 2 - 8°C until expiration date |
| Calibrator Form | Liquid | Liquid |
| Calibrator Levels | One (1) Level (100ng/mL or | |
| 300ng/mL) | One (1) Level (100ng/mL or | |
| 300ng/mL) | ||
| Control Set Levels | Two (2) Levels (75ng/mL and | |
| 125ng/mL or 225ng/mL and 375 | ||
| ng/mL) | Two (2) Levels (75ng/mL and | |
| 125ng/mL or 225ng/mL and 375 | ||
| ng/mL) | ||
| Calibrator Set | ||
| Levels | Five (5) Levels (0, 100, 300, 500 | |
| and 1000 ng/mL) | Five (5) Levels (0, 100, 300, 500 | |
| and 1000 ng/mL) |
- G. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Oxycodone Urine Enzyme Immunoassay to the predicate
-
- Precision/ Cutoff Characterization
-
- Specificity and Cross-Reactivity
-
- Interference
-
- Linearity/ Recovery
- Method Comparison 5.
-
- Stability
-
- H. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis Oxycodone Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use. The information supplied in this pre-market notification provides reasonable assurance that the Immunalysis Oxycodone Urine Enzyme Immunoassay is safe and effective for its intended use
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2014
IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST 829 TOWNE CENTER DR. POMONA CA 91767
Re: K131168
Trade/Device Name: Immunalysis Oxycodone Enzyme Immunoassay Immunalysis Oxycodone Urine Controls Immunalysis Oxycodone Urine Calibrators Regulation Number: 21 CFR 862.3650
Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DLJ, LAS Dated: December 20, 2013 Received: December 26, 2013
Dear Mr. Ginete:
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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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Page 2-Mr. Ginete
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES
510(k) Number (if known) K131168
Device Name
Immunalysis Oxycolone Urine Enzync, Immunilysis Oxycodone Urine Controls and Immunalysis Oxycodone Urine Calbrators
Indications for Use (Describe)
Immunalysis Oxycodone Urine Enzyme Immunoassay:
The Immunalysis Oxycodone Urine Enzyne ImmunosAssay is a homogencous enzyne inimunossay with a dual cutoff of 100ng/ml and 300ng/mL. The assay is intended for use in laboratories for the qualitative and seni-quantitative analysis of Oxycodone in human urine with automated clinical chemistry and rated against Oxycodone. This in-viro device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for continuation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Inmunalysis Oxycodone Urine Enzyne Inununoassay Kit provides only a preliminary analytical test result. A more specific allemate chemical method must be obtain a confirmed analytical result. Gas Chromatography/ Nass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be any drug of abuse test result, particularly when preliminary positive results are used.
Immunalysis Oxycodone Urine Controls:
The Immunalysis Oxycodone Urine Control naterials in the Innunalysis Oxycodone Urine Enzyne Immunoassay.
Immunalysis Oxycodone Urine Calibrators:
The Innunalysis Oxycodore Urine Calibrators are used as calibrators in the Inmunalysis Oxycodone Urine Enzyne Inimunoassay for the qualitative and semi-quantitation of Oxycodone in urine on automated clinical chemistry analyzers.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
PSC Publishing Services (301) 443-6740 EP
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.