(412 days)
The Omega Laboratories Hair Drug Screening Assays are test systems that utilize ELISA assays for the qualitative detection of morphine and related opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in head hair samples.
The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone provide only preliminary analytical test results. A more specific alternate chemical method must be used in order to obtain a confirmed result. Gas Chromatograph – Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
These laboratory developed tests are intended exclusively for in-house professional use only and are not intended for sale to anyone. Omega offers these laboratory developed tests as services to its clients.
The Omega Laboratories Hair Drug Screening Assays for Opiates, Oxycodone and Hydrocodone are test systems using ELISA reagents and micro-plate reader for the qualitative detection of Opiates, Oxycodone and Hydrocodone in hair samples at or above 300 pg/mg.
The provided text describes a 510(k) submission for a hair drug screening assay. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a new, unique device. Therefore, many of the requested sections (e.g., acceptance criteria table, detailed sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies) are not explicitly present in the provided document, as a different type of evidence is required for a substantial equivalence claim for an immunoassay.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
For devices demonstrating substantial equivalence through comparison to predicate devices, the "acceptance criteria" are generally that the new device's performance characteristics (precision, analytical sensitivity, interference, antibody cross-reactivity, and qualitative results in donor specimens) are "in substantial agreement" with or "substantially equivalent" to the predicate. Specific numerical thresholds for these criteria are not provided in this summary, as is common for this type of submission.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial agreement with predicate devices for Opiates | "The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone... yields results in substantial agreement with the predicate device [Quest Diagnostics HairCheck-DT (Opiates) K042725]." "Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the Omega assays are in substantial agreement with the Quest Diagnostic..." "Results obtained from donor specimens showed that the qualitative results from the new assays are substantially equivalent to those obtained from the predicate devices." |
| Substantial agreement with predicate devices for Oxycodone | "The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone... yields results in substantial agreement with the predicate device [RadipOne -OXY Test (American Bio Medica Corporation) (Oxycodone) K014101]." "Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the Omega assays are in substantial agreement with the... American Bio Medica products." "Results obtained from donor specimens showed that the qualitative results from the new assays are substantially equivalent to those obtained from the predicate devices." |
| Substantial agreement with predicate devices for Hydrocodone | "The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone... yields results in substantial agreement with the predicate device [implicitly, through comparison to opiate/oxycodone predicate for the panel]." "Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the Omega assays are in substantial agreement with the Quest Diagnostic and American Bio Medica products." "Results obtained from donor specimens showed that the qualitative results from the new assays are substantially equivalent to those obtained from the predicate devices." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "Results obtained from donor specimens," but does not specify the sample size for these donor specimens.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a diagnostic assay, it's highly probable these were controlled prospective studies conducted at the manufacturer's or a contract research organization's laboratory, likely within the US, but this is not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable or required for an immunoassay 510(k) submission focused on analytical performance and substantial equivalence. The "ground truth" for a performance study of such a device generally refers to the confirmed analytical result, typically established by a gold standard method (like GC/MS or GC/MS/MS), not by human expert interpretation like in imaging studies.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" for an immunoassay's analytical performance is based on chemical or instrumental confirmation, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device is an ELISA-based qualitative drug screening assay, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers. Therefore, an MRMC study or AI assistance is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the AI sense. The device is a standalone assay system (reagents and micro-plate reader) that provides a qualitative result. Its performance is determined analytically, independent of direct human interpretation influencing the primary result. However, it provides "preliminary analytical test results," explicitly stating that "A more specific alternate chemical method must be used in order to obtain a confirmed result." This implies it's a screening tool, not a definitive diagnostic, and further human interpretation of confirmed results would occur elsewhere.
7. The Type of Ground Truth Used
The document explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed result. Gas Chromatograph – Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards."
Therefore, the ground truth for this device's performance comparison is established using confirmatory analytical methods (GC/MS or GC/MS/MS), which are considered the gold standard for drug detection. This is not expert consensus, pathology, or outcomes data in the typical sense for medical imaging or clinical trials.
8. The Sample Size for the Training Set
The document is for a 510(k) of an ELISA assay, not an AI/ML model. Therefore, the concept of a "training set" for model development is not applicable in the way it would be for an AI device. The assay development would involve optimizing reagent formulations and protocols, but not "training" a machine learning algorithm on data.
9. How the Ground Truth for the Training Set was Established
As explained in point 8, the concept of a "training set" is not applicable in the context of this device's chemistry-based assay development.
{0}------------------------------------------------
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the
requirements of SMDA 1990 and 21 CFF 807.92
| 510(k) Number: | K103161 |
|---|---|
| Date of Summary: | June 14, 2011 |
| Applicant: | William R. CoriVice President of OperationsOmega Laboratories, Inc.400 North ClevelandMogadore, OH 44260Tel: 330-628-5748Fax: 330-628-5803 |
| Correspondent:Name: | Robert J Bard, JD |
| Address: | Omega Laboratories400 North Cleveland, Mogadore, OH 44260 |
| Phone Number:E-mail | 248-573-5040rbard@reglaw.net |
| Product Name:Trade Name: | Omega Laboratories Hair Drug Screening Assay for Opiates,Oxycodone and Hydrocodone |
| Common Name: | Hair Drug Screening Assay Opiates |
| Regulation Number: | CFR 862.3650 (ProCode DJG) |
| Predicate Device: | Quest Diagnostics HairCheck-DT (Opiates) K042725; RadipOne -OXYTest (American Bio Medica Corporation) (Oxycodone) K014101 |
| Product Description: | The Omega Laboratories Hair Drug Screening Assays for Opiates,Oxycodone and Hydrocodone are test systems using ELISA reagentsand micro-plate reader for the qualitative detection of Opiates,Oxycodone and Hydrocodone in hair samples at or above 300 pg/mg. |
| Indication for Use: | The Omega Laboratories Hair Drug Screening Assays are test systemsthat utilize ELISA assays for the qualitative detection of morphine andrelated opiates (calibrated with morphine) and oxycodone andhydrocodone (calibrated with oxycodone) at or above 300 pg/mg inhead hair samples.The Omega Laboratories Hair Drug Screening Assay for Opiates,Oxycodone and Hydrocodone provide only preliminary analytical testresults. A more specific alternate chemical method must be used inorder to obtain a confirmed result. Gas Chromatograph – MassSpectrometry operating in the selected ion monitoring (SIM) mode orGC/MS/MS in selected reaction mode (SRM) is the preferred methodwith deuterated internal standards. |
| Comparison: | When used to qualitatively detect Opiates, Oxycodone andHydrocodone in head hair specimens collected with the Omega |
{1}------------------------------------------------
Comparison Performance Data:
Specimen Collection Device, the Omega assays vield results in substantial agreement with the predicate device.
Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the Omega assays are in substantial agreement with the Quest Diagnostic and American Bio Medica products.
Results obtained from donor specimens showed that the qualitative results from the new assays are substantially equivalent to those obtained from the predicate devices.
Conclusion:
The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone is substantially equivalent to the Quest Diagnostics HairCheck-DT (Opiates) K042725; RadipOne -OXY Test (American Bio Medica Corporation) (Oxycodone) K014101 and can be used to qualitatively screen hair specimens collected with the Omega Specimen Collection Device for Opiates, Oxycodone and Hydrocodone.
{2}------------------------------------------------
10903 New Hampshire Avenue Silver Spring, MD 20993
DEC 13 2004
OMEGA Laboratories c/o HealthCare Technologies Consultants c/o Robert Bard P. O. Box 506 South Lyon, MI 48178
Re: K103161
Trade Name: Omega Laboratories Hair Drug Screening Assays for Opiates, Oxycodone and Hydrocodone Regulation Number: 21 CFR §862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Codes: DJG Dated: November 28, 2011 Received: November 30, 2011
Dear Mr. Bard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{3}------------------------------------------------
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours.
Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indication for Use
Device Name: Omega Laboratories Hair Drug Screening Assays for Opiates, Oxycodone and Hydrocodone.
Indication for Use:
The Omega Laboratories Hair Drug Screening Assays are test systems that utilize ELISA assays for the qualitative detection of morphine and related opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in head hair samples.
The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone provide only preliminary analytical test results. A more specific alternate chemical method must be used in order to obtain a confirmed result. Gas Chromatograph – Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
These laboratory developed tests are intended exclusively for in-house professional use only and are not intended for sale to anyone. Omega offers these laboratory developed tests as services to its clients.
Prescription Use __ __________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D)
Over the Counter Use __X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103/6/
§ 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).