(412 days)
No
The summary describes a laboratory test using ELISA and a micro-plate reader for qualitative drug detection. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a diagnostic test system used for qualitative detection of substances in hair samples, not for treating or preventing disease.
Yes
The device is a test system that detects the presence of specific substances (morphine, opiates, oxycodone, and hydrocodone) in hair samples, providing preliminary analytical test results to inform subsequent confirmatory testing and professional judgment regarding drug use.
No
The device description explicitly states it uses "ELISA reagents and micro-plate reader," which are hardware components.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the assays are "test systems that utilize ELISA assays for the qualitative detection of morphine and related opiates... and oxycodone and hydrocodone... in head hair samples." This describes a test performed in vitro (outside the body) on a biological specimen (hair) to provide information about a person's health status (presence of drugs).
- Device Description: The description further clarifies that it's a "test system using ELISA reagents and micro-plate reader for the qualitative detection of Opiates, Oxycodone and Hydrocodone in hair samples." This aligns with the definition of an IVD, which involves reagents and instruments used to examine specimens from the human body.
- Predicate Devices: The mention of predicate devices (Quest Diagnostics HairCheck-DT and RadipOne -OXY Test) which are known IVDs, further supports the classification of this device as an IVD.
- Performance Studies: The description of performance studies on precision, analytical sensitivity, interference, and antibody cross-reactivity are typical evaluations performed for IVD devices.
While the device is described as a "laboratory developed test" intended for "in-house professional use only" and "not intended for sale to anyone," this describes the distribution and use model of the IVD, not whether it is an IVD. The core function of the device is to perform a diagnostic test on a biological sample in vitro, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications 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.
Product codes
DJG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head hair samples
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-house professional 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Quest Diagnostics HairCheck-DT (Opiates) K042725, RadipOne -OXY Test (American Bio Medica Corporation) (Oxycodone) K014101
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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. Cori |
| Vice President of Operations |
Omega Laboratories, Inc.
400 North Cleveland
Mogadore, OH 44260
Tel: 330-628-5748
Fax: 330-628-5803 |
| Correspondent:
Name: | Robert J Bard, JD |
| Address: | Omega Laboratories
400 North Cleveland, Mogadore, OH 44260 |
| Phone Number:
E-mail | 248-573-5040
rbard@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 -OXY
Test (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 reagents
and 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 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. |
| Comparison: | When used to qualitatively detect Opiates, Oxycodone and
Hydrocodone 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/