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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Immunalysis Oxycodone Urine Enzyme Immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity, specificity thresholds) or specific numerical performance metrics in a readily digestible format for the Immunalysis Oxycodone Urine Enzyme Immunoassay. However, it mentions several laboratory performance studies conducted to establish "substantial equivalence" to the predicate device. These study types implicitly represent areas where the device performance was evaluated.

While no precise acceptance criteria (e.g., "sensitivity must be >95%") are given, the comparison table between the predicate and the test device indicates that the "Cutoff Levels" are identical (100ng/mL and 300ng/mL of Oxycodone). This suggests that the device's ability to accurately detect beyond these cutoffs is a key performance metric. The "Conclusion" section states the device is "safe and effective for its intended use" and "substantially equivalent" to the predicate, implying that its performance in the conducted studies met the unstated acceptance criteria for these categories.

Performance Metric Category	Implicit Acceptance Criterion (based on substantial equivalence)	Reported Device Performance (as implied by conclusion)
Cutoff Characterization/Precision	Demonstrate accurate detection at or around 100ng/mL and 300ng/mL cutoffs.	Performance deemed "substantially equivalent" to predicate.
Specificity and Cross-Reactivity	Minimal cross-reactivity with common interfering substances; high specificity for oxycodone.	Performance deemed "substantially equivalent" to predicate.
Interference	Not significantly affected by common endogenous or exogenous interfering substances in urine.	Performance deemed "substantially equivalent" to predicate.
Linearity/Recovery	Accurate measurement across a range of oxycodone concentrations.	Performance deemed "substantially equivalent" to predicate.
Method Comparison	Results correlate well with a recognized reference method (and the predicate device).	Performance deemed "substantially equivalent" to predicate.
Stability	Maintain performance characteristics over its stated shelf life and storage conditions (2-8°C).	Performance deemed "substantially equivalent" to predicate. (Likely passed internal criteria)
Qualitative/Semi-Quantitative Analysis	Accurately categorize samples as positive/negative and provide semi-quantitative estimations.	Performance deemed "substantially equivalent" to predicate.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state the sample size used for any of the test sets (Precision/Cutoff Characterization, Specificity, Interference, Linearity, Method Comparison, Stability).

The document does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of sample collection).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The provided text does not mention the use of experts to establish ground truth for the test set. For an in-vitro diagnostic device like this, ground truth is typically established through reference methods (like GC-MS or LC/MS) rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method like 2+1 or 3+1. For in-vitro diagnostic assays, adjudication methods are less common, as analytical results are compared to a more definitive reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in the provided text. This type of study is more relevant for imaging devices where human readers interpret results, and the AI's impact on their performance is directly measured. This device is an automated immunoassay.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The studies described (Precision, Specificity, Interference, Linearity, Method Comparison, Stability) are inherent to the standalone performance of the assay itself. The immunoassay is an automated system designed to produce results, and the listed studies directly evaluate its analytical capabilities. Therefore, a standalone performance evaluation was done through these studies, as there isn't a "human-in-the-loop" component in the assay's primary function. The output is a preliminary analytical test result.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is implicitly through a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (LC/MS). The intended use statement explicitly states: "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." This indicates that these methods serve as the gold standard for confirming oxycodone presence and concentration.

8. Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This is an immunoassay, which relies on chemical reactions and optical detection, not a machine learning or AI algorithm that typically requires a distinct training set. The "assay" itself is the "algorithm" in a sense, and its formulation and optimization would precede these validation studies.

9. How the Ground Truth for the Training Set Was Established

Since no specific "training set" for an AI or machine learning model is mentioned, the text does not describe how ground truth for a training set was established.

Summary

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K131168

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

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İMMUNALYSIS

D. Device Description

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.

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:

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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 ofOxycodone	100ng/mL and 300ng/mL ofOxycodone
Test System	Homogenous EnzymeImmunoassay	Homogenous EnzymeImmunoassay
Materials	Antibody/ Substrate Reagents andEnzyme Labeled Conjugate	Antibody/ Substrate Reagents andEnzyme Labeled Conjugate
Mass SpectroscopyConfirmation	Required for preliminary positiveanalytical results	Required for preliminary positiveanalytical results
Antibody	Mouse monoclonal anti-oxycodonederivative	Recombinant FAB Antibody toOxycodone
Storage	2 - 8°C until expiration date	2 - 8°C until expiration date
Calibrator Form	Liquid	Liquid
Calibrator Levels	One (1) Level (100ng/mL or300ng/mL)	One (1) Level (100ng/mL or300ng/mL)
Control Set Levels	Two (2) Levels (75ng/mL and125ng/mL or 225ng/mL and 375ng/mL)	Two (2) Levels (75ng/mL and125ng/mL or 225ng/mL and 375ng/mL)
Calibrator SetLevels	Five (5) Levels (0, 100, 300, 500and 1000 ng/mL)	Five (5) Levels (0, 100, 300, 500and 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
- 1. Precision/ Cutoff Characterization
- 1. Specificity and Cross-Reactivity
- 1. Interference
- 1. Linearity/ Recovery
- Method Comparison 5.
- 1. 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

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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

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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.

Regulation Number and Section

§ 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).