IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) by LIFEPOINT,INC

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.

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided text is a 510(k) summary for the LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate. This type of document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed performance studies against specific acceptance criteria. While it mentions the device's intended use and performance characteristics, it does not provide a dedicated section outlining specific acceptance criteria or a detailed study proving the device meets them in the manner typically seen for novel device approvals.

Therefore, many of the requested items cannot be directly extracted from this document. However, I will infer and present the information that is available or implicitly stated.

Inferred Acceptance Criteria & Reported Performance:

The primary "acceptance criteria" for a 510(k) device like this hinge on its ability to provide qualitative screening results for Opiate at a specific cut-off value and to do so reliably for its intended use and user group. The reported performance is primarily descriptive of its function rather than a quantitative measurement against a pre-defined threshold.

Acceptance Criteria (Implied)	Reported Device Performance
Qualitative Screening for Opiate at a specific cut-off value	Provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL.
Intended Use Environment	For in vitro diagnostic workplace use.
User Proficiency	Operable by individuals with no prior laboratory testing education or experience, provided they receive specified training, demonstrate competency, and understand potential for false positive/negative results.
Integration with Instrument	The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument. (This implies proper function and communication between the module and the instrument is an unstated criterion).
Confirmation Need	Provides only a preliminary result; a more specific alternate chemical method (e.g., GC/MS) is needed for confirmed analytical results. (This is a limitation that must be met, not a performance metric per se, but it defines the scope of its "acceptance" as a screening tool).

Detailed Breakdown for Study and Criteria:

Since the document is a 510(k) and not a full clinical study report, specific details regarding sample sizes, ground truth establishment, expert qualifications, and detailed statistical analyses are not included in the provided text.

A table of acceptance criteria and the reported device performance:
(See table above)
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. (It's a 510(k), not a study report).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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:
- Not applicable/mentioned. This is an in vitro diagnostic device for substance detection, not an AI-assisted diagnostic imaging or interpretation tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is inherently a "standalone" test system (albeit with a required instrument). It provides a result based on chemical reaction detection. The "human-in-the-loop" aspect comes from the user performing the test and interpreting the preliminary result, but the device itself generates the screening result without human interpretation of raw data. The document does not describe separate algorithm-only performance testing beyond the intended use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- While not explicitly stated for a "test set," the document implicitly refers to Gas Chromatography/Mass Spectroscopy (GC/MS) as the "preferred confirmation method" for analytical results. This strongly suggests that GC/MS would be the gold standard or ground truth for confirming the presence and concentration of opiates in human saliva during validation studies for such a device.
The sample size for the training set:
- Not applicable/specified. This type of device does not typically involve a "training set" in the machine learning sense. Its performance is based on chemical assay characteristics, not learned patterns.
How the ground truth for the training set was established:
- Not applicable. (See #8).

Summary

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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).

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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,

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

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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.

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

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).