(148 days)
Not Found
None
No
The summary describes a rapid qualitative immunoassay for drug screening and does not mention any computational analysis or algorithms that would suggest the use of AI or ML.
No.
This device is for in vitro diagnostic workplace use and is described as a single-drug test for rapid determination of Opiate in human saliva, providing only qualitative screening results. It does not provide any therapeutic function.
Yes
The intended use states "For in vitro diagnostic workplace use" and describes the device as a "single-drug test for the rapid determination of Opiate in human saliva."
No
The device description explicitly mentions a "disposable STM" (Saliva Test Module) and a "LifePoint IMPACT Test System instrument," indicating the presence of physical hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first line explicitly states "For in vitro diagnostic workplace use." It also describes the device as a "single-drug test for the rapid determination of Opiate in human saliva," which is a biological sample tested in vitro (outside the body).
- Anatomical Site: It specifies "human saliva," which is a biological specimen.
- Purpose: The purpose is to provide "qualitative screening results for Opiate," which is a diagnostic test to detect the presence of a substance in a biological sample.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic workplace use. The LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate is a professional use single-drug test for the rapid determination of Opiate in human saliva. It provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL. The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
Operators that may use this device are defined as individuals with no prior laboratory testing education or experience, and (1) have received training; a copy of the training checklist, which describes the topics to be covered during this orientation are included in the appendix of the Users Manual, (2) training includes a demonstration of the IMPACT test system and the use of Quality Check (CATALOG #2160) for monitoring and confirming the performance of the test system., (3) trainers monitor operators and confirm their competency and technique in running a test sample and quality control samples, (4) trainers confirm that operators can perform basic troubleshooting procedures, and their understanding of test results, including a discussion of the potential for false positive and false negative results and how to prepare a sample for shipment to a facility for confirmation testing, (5) have reviewed the information contained in the IMPACT Test System Quick Reference Guide and Users Manual., (6) have successfully taken a written exam to verify their competency and obtained a test score of at least 80% on the written examination provided in the appendix of the Users Manual, and (7) have access to assistance from an individual who is experienced in laboratory equipment, and who is familiar with the interpretation of drug testing results.
It is the responsibility of those organizations required to follow Department of Transportation (DOT) or Substance Abuse and Mental Health Services Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfies the criteria for workplace testing established under DOT and SAMHSA authority.
Product codes
DJG, KHO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human saliva
Indicated Patient Age Range
Not Found
Intended User / Care Setting
workplace use. Operators that may use this device are defined as individuals with no prior laboratory testing education or experience, and (1) have received training; a copy of the training checklist, which describes the topics to be covered during this orientation are included in the appendix of the Users Manual, (2) training includes a demonstration of the IMPACT test system and the use of Quality Check (CATALOG #2160) for monitoring and confirming the performance of the test system., (3) trainers monitor operators and confirm their competency and technique in running a test sample and quality control samples, (4) trainers confirm that operators can perform basic troubleshooting procedures, and their understanding of test results, including a discussion of the potential for false positive and false negative results and how to prepare a sample for shipment to a facility for confirmation testing, (5) have reviewed the information contained in the IMPACT Test System Quick Reference Guide and Users Manual., (6) have successfully taken a written exam to verify their competency and obtained a test score of at least 80% on the written examination provided in the appendix of the Users Manual, and (7) have access to assistance from an individual who is experienced in laboratory equipment, and who is familiar with the interpretation of drug testing results.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure with three stylized wings or feathers.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 4 2004
David B. Goldberg, Ph.D. Director, Regulatory Affairs and Quality Systems LifePoint, Inc. 1205 South Dupont Street Ontario, CA 91761
Re: K041747
Trade/Device Name: IMPACT Test System; Saliva Test Module- Opiate Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, KHO Dated: October 25, 2004 Received: October 26, 2004
Dear Dr. Goldberg:
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. Iisting 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
1
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Cornelia B. Lorks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): K04 1747/5001
Device Name: IMPACT Test System; Saliva Test Module - Opiate
Indications For Use: For in vitro diagnostic workplace use. The LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate is a professional use single-drug test for the rapid determination of Opiate in human saliva. It provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL. The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
Operators that may use this device are defined as individuals with no prior laboratory testing education or experience, and (1) have received training; a copy of the training checklist, which describes the topics to be covered during this orientation are included in the appendix of the Users Manual, (2) training includes a demonstration of the IMPACT test system and the use of Quality Check (CATALOG #2160) for monitoring and confirming the performance of the test system., (3) trainers monitor operators and confirm their competency and technique in running a test sample and quality control samples, (4) trainers confirm that operators can perform basic troubleshooting procedures, and their understanding of test results, including a discussion of the potential for false positive and false negative results and how to prepare a sample for shipment to a facility for confirmation testing, (5) have reviewed the information contained in the IMPACT Test System Quick Reference Guide and Users Manual., (6) have successfully taken a written exam to verify their competency and obtained a test score of at least 80% on the written examination provided in the appendix of the Users Manual, and (7) have access to assistance from an individual who is experienced in laboratory equipment, and who is familiar with the interpretation of drug testing results.
It is the responsibility of those organizations required to follow Department of Transportation (DOT) or Substance Abuse and Mental Health Services Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfies the criteria for workplace testing established under DOT and SAMHSA authority.
| Prescription Use | |
|---|---|
| OR | |
| OTC Use | X |
| (Workplace) |
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
510(k) K041747