(399 days)
Not Found
No
The summary describes a laboratory developed test using ELISA and a micro-plate reader for qualitative detection of substances in hair. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a diagnostic tool used for screening purposes (detecting specific drugs in hair samples), not for treating any condition or disease.
No
This device is for drug screening, specifically identifying the presence of Methamphetamine and MDMA in hair, which is a screening test rather than a diagnostic device for a disease or condition. It is used to identify the use of substances, not to diagnose a medical condition.
No
The device description explicitly states it uses "ELISA reagents and micro-plate reader," which are hardware components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to determine the presence of Methamphetamine and MDMA in human hair. This is a diagnostic purpose, specifically for identifying the use of these substances.
- Sample Type: It uses human hair, which is a biological specimen taken from the body.
- Method: It utilizes an ELISA (Enzyme-Linked Immunosorbent Assay) and a micro-plate reader, which are common laboratory techniques for analyzing biological samples.
- Purpose: The purpose is to provide information about a person's physiological state (presence of drugs in their system).
While it is a laboratory developed test intended for in-house use and not for sale, the fundamental nature of the test - analyzing a biological sample to diagnose or provide information about a health condition or state - aligns with the definition of an In Vitro Diagnostic device. The fact that it is a service offered to clients further supports its diagnostic purpose.
N/A
Intended Use / Indications for Use
The Omega Laboratories Hair Drug Screening Assay for Methamphetamine and MDMA is a laboratory developed test that is intended to be used for the determination of the presence of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. The Omega Laboratories Hair Drug Screening Assay (AMP) utilizes International Diagnostics Systems Corp One-Step Methamphetamine ELISA for Hair Testing Kit for the qualitative detection of Methamphetamine and MDMA at or above 500 pg/mg of hair for the purpose of identifying the use of Methamphetamine and MDMA. D-Methamphetamine is used as the standard for the assay. To confirm a screen positive result a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.
This laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers this laboratory developed test as a service to its clients.
Product codes (comma separated list FDA assigned to the subject device)
LAF
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
human hair from the crown of the head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-house laboratory 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 were conducted for Precision, Agreement, Cosmetic Treatment, Cross-reactivity, Environmental Contamination.
All performance studies demonstrated that the Omega assay is in substantial agreement with the Quest Diagnostic product.
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.
Quest Diagnostics HairCheck-DT (Amphetamines) K051161
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
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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 CFR 807.92
510(k) Number: | K101973 |
---|---|
Date of Summary: | August 2, 2011 |
Applicant: | William R. Corl |
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: | 248-573-5040 |
rbard@reglaw.net | |
Product Name: | |
Trade Name: | the Omega Laboratories Hair Drug Screening Assay |
Methamphetamine_3, 4-methylenedioxymethamphetamine | |
(Meth_MDMA) | |
Common Name: | Hair Drug Screening Assay Methamphetamine |
Regulation Number: | CFR 862.3610 (ProCode LAF) |
Classification Name: | Enzyme immunoassay, Methamphetamine |
Methamphetamine test System | |
Classification Panel: | 91 (Toxicology) |
Predicate Device: | Quest Diagnostics HairCheck-DT (Amphetamines) K051161; |
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 Assay for |
Methamphetamine and MDMA is a laboratory developed test that is | |
intended to be used for the determination of the presence of | |
Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) | |
in human hair from the crown of the head. The Omega Laboratories | |
Hair Drug Screening Assay (AMP) utilizes International Diagnostics | |
Systems Corp One-Step Methamphetamine ELISA for Hair Testing Kit | |
for the qualitative detection of Methamphetamine and MDMA at or | |
above 500 pg/mg of hair for the purpose of identifying the use of | |
Methamphetamine and MDMA. D-Methamphetamine is used as the |
1
| | standard for the assay. To confirm a screen positive result a more
specific alternate chemical method, such as Gas
Chromatography/Mass Spectrometry (GC/MS) operating in the selected
ion monitoring (SIM) mode is the preferred method with deuterated
internal standards. Professional judgment should be applied to any
drug of abuse test result, particularly when presumptive positive results
are obtained. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | When used to qualitatively detect methamphetamine and/or MDMA in
head hair specimens collected with the Omega Specimen Collection
Device, the Omega assays yield results in substantial agreement with
the predicate device. |
| Comparison Performance
Data: | Performance characteristic studies were conducted for |
| | Precision |
| | Agreement |
| | Cosmetic Treatment |
| | Cross-reactivity |
| | Environmental Contamination |
| All performance studies demonstrated that the Omega assay is in
substantial agreement with the Quest Diagnostic product. | |
| 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
Methamphetamine and MDMA is substantially equivalent to the Quest
Diagnostics HairCheck-DT (Amphetamines) K051161. |
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
AUG 1 8 2011
Omega Laboratories, Inc. c/o Mr. Robert J Bard JD Managing Director PO Box 506 South Lyon, Michigan 48178
Re: K101973
Trade Name: Omega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-Methylenedioxymethamphetamine (MDMA) Regulation Number: 862.3610 Regulatory Class: Class II Product Codes: LAF Dated: August 02, 2011 Received: August 05, 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 -
11 you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. 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 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/cdrlv/industry/support/index.html.
Sincerely vours.
G.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology 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 Assay Methamphetamine and 4-Methylenedioxymethamphetamine (MDMA)
Indication for Use:
The Omega Laboratories Hair Drug Screening Assay Methamphetamine and ,4-Methylenedioxymethamphetamine (MDMA) is a laboratory developed test that is intended to be used for the determination of the presence of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. The Omega Laboratories Hair Drug Screening Assay (Meth MDMA) utilizes International Diagnostics Systems Corp One-Step Methamphetamine ELISA for Hair Testing Kit for the qualitative detection of Methamphetamine and MDMA at or above 500 pg/mg of hair for the purpose of identifying the use of Methamphetamine and MDMA. D-Methamphetamine is used as the standard for the assay. To confirm a screen positive result a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.
This laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers this laboratory developed test as a service 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)
RA
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101973