(56 days)
The Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is a single-unit screening test for the rapid detection of two to six of the above drugs in human urine. The designated cutoff concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided.
The Accu-Stat™ Home Drug Test for Marijuana, Cocaine, Amphctamine, Methamphetamine, Opiates, and Phencyclidine, like other commercially available drug screening tests, qualitatively measures the presence or absence of THC, COC, AMP, mAMP, OPI, PCP and their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of competitive binding. Drugs, which may be present in the urine specimen, compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/ml, and the other drugs being tested for, if below the cut-off levels stated above, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized marijuana, cocaine, or other listed drug conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above the 50 ng/ml because it will saturate all the binding sites of antimarijuana antibodies. The same holds true for cocaine and the other drugs if the level is above the cut-off. It will saturate all the binding sites of anticocaine (or other drug) antibodies and therefore the colored line will not form in the test region.
A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of a drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.
The provided text describes a 510(k) premarket notification for the Accu-Stat™ Home Drug Test. It details the device's intended use and the basis for its substantial equivalence to predicate devices, but it does not contain a study or data proving the device meets specific acceptance criteria in the format requested.
The document discusses "consumer studies" that demonstrate "excellent overall performance in the hands of lay users" and states that "the data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests." However, it does not provide the specifics of these studies, such as sample size, methodology, or detailed results, nor does it define explicit acceptance criteria with corresponding performance metrics.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's an attempt to answer based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format (e.g., sensitivity, specificity thresholds) or present a table of device performance against such criteria. It generally claims "excellent overall performance."
The cut-off concentrations for the drugs are specified, which act as de facto performance targets:
- Marijuana: 50 ng/ml
- Cocaine: 300 ng/ml
- Amphetamine: 1000 ng/ml
- Methamphetamine: 1000 ng/ml
- Opiates: 2000 ng/ml
- Phencyclidine: 25 ng/ml
The operating principle described is that if the drug level is above the cut-off, a line will not form (positive result), and if below, a line will form (negative result).
Reported Device Performance:
The document states: "The consumer studies using the Accu-Stat™ Home Drug Test... demonstrates that the test exhibits excellent overall performance in the hands of lay users." No quantitative data like sensitivity, specificity, or accuracy percentages are provided to back this claim in the given text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "consumer studies" but does not specify the sample size, the country of origin of the data, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth for any test sets. The tests are for OTC consumer use, and the "two-step process" includes "confirmatory testing of preliminary positive results" by a laboratory, implying the ground truth for positive cases would be lab-confirmed, but details on this are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified in the provided text. The "two-step process" implies an external lab confirmation for positive results, which serves as a form of adjudication for those specific results, but the method for the initial screening interpretations is not detailed.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a rapid chromatographic immunoassay, not an AI-based system. Therefore, the question about human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a qualitative immunoassay test, not an algorithm. Its performance is inherent in its chemical reaction. The "standalone" performance is essentially its ability to react correctly to drug levels. The primary "human-in-the-loop" aspect is the consumer's interpretation of the line, which the document claims is "excellent overall performance in the hands of lay users." However, no specific study data for this standalone performance is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth implicitly used for positive results would be laboratory confirmatory testing. For negative results, it's the absence of the drug below the cut-off. The document states: "intended for over-the-counter (OTC) consumer use as the first step in a two-step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided."
8. The sample size for the training set
The document does not refer to a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
{0}------------------------------------------------
MAY - 5 2004
Section D
510(k) Summary J As required by 21 CFR 807.92 ]
I. Submitter: A. Name: Accu-Stat Diagnostics, Inc. B. Address: 11 Orchard Road, Suite # 108, Lake Forest, CA 92630 C. Phone and Fax Numbers: Phone 949-916-7560 949-916-7595 Fax D. Contact Person: James G. Barrons Date of Preparation of this Summary: 9 March 2004 II. Trade Name: Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine III. (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) Common Name: At home rapid screening test for Marijuana (THC), Cocaine IV. (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) in urine. Classification Name: Immunoassay for the qualitative detection of drugs of V. abuse in urine. VI. The Marketed Products to Which Equivalence is claimed: The Accu-Stat™Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is substantially equivalent to the First Check® Home Drug Test for Marijuana, Cocaine, Mcthamphetamine, & Opiates (K993852), and the Phamatech At Home™ Drug Test for Amphetamine, Methamphetamine (Ecstasy), Marijuana, Cocaine, and Opiates (K003858), and other commercially available drug screening tests that qualitatively measure the presence of target drugs or metabolites by visual color one-step immunoassay technology.
- VII. Statement of Intended Use Compared to Other Products: The intended use of the Accu-Stat™ Home Drug Tests for Marijuana. Cocaine, Amphetamine, Opiates, Methamphetamine, and Phencyclidine is substantially equivalent to the above listed products and is a single unit screening test for the detection of from two to six of the listed drugs in human urine. The designated cut-off concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine
{1}------------------------------------------------
at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. These tests are intended for over-the-counter (OTC) consumer use as the first step in a twostep process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urinc specimen to the laboratory is provided.
- Discussion of Technological Characteristics: The Accu-Stat™ Home Drug VIII. Test for Marijuana, Cocaine, Amphctamine, Methamphetamine, Opiates, and Phencyclidine, like other commercially available drug screening tests, qualitatively measures the presence or absence of THC, COC, AMP, mAMP, OPI, PCP and their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of competitive binding. Drugs, which may be present in the urine specimen, compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/ml, and the other drugs being tested for, if below the cut-off levels stated above, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized marijuana, cocaine, or other listed drug conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above the 50 ng/ml because it will saturate all the binding sites of antimarijuana antibodies. The same holds true for cocaine and the other drugs if the level is above the cut-off. It will saturate all the binding sites of anticocaine (or other drug) antibodies and therefore the colored line will not form in the test region.
A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of a drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.
Examples of predicate devices include the First Check® Home Drug Tests and the Phamatech At Home Drug Tests using a single or a multi-drug display. The consumer studies using the Accu-Stat™ Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine Opiates, and Phencyclidine demonstrates that the test exhibits excellent overall performance in the hands of lay users. The data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests to obtain immediate, preliminary information regarding the possible use of THC, COC, AMP, mAMP, OPI, and PCP.
- IX. Safety and Effectiveness: Because the Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine,
{2}------------------------------------------------
(mAMP), Opiates (OPI), and Phencyclidine are identical to the ACON Laboratories One Step Multi-Drug Multi-Line Screen Test Device that is legally marketed under K020313 for professional use, and because no special skills, training, education, or licensing is required to transfer a few drops of a urine sample into the test card well, there is no issue regarding the safety or effectiveness of the product to perform its intended function, i.e., to screen urine for the presence or absence of THC, COC, AMP, mAMP, OPI, or PCP and their metabolite(s). Because the labeling of the Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the First Check® Home Drug Test, the Advantage Diagnostics Home Drug Tests and the Phamatech At Home™ Drug Tests, and there have been no reports of consumer inability to follow instructions or interpret results over the many months these products have been purchased, it should be concluded that the product can be used effectively by the lay user.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 5 2004
Mr James G. Barrons President Accu- Stat Diagnostics, Inc. 11 Orchard Road Suite 108 Lake Forest, CA 92630
K040629 Re:
Trade/Device Name: Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DKZ, MVO, DIO, LAF, DJG, and LCM Dated: March 9, 2004 Received: March 10, 2004
Dear Mr. Barrons:
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 he advised that FDA's issuance of a substantial cquivalence 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).
{4}------------------------------------------------
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,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Section A
Indications for Use
510(k) Number (if known): K040629
Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Device Name: Ambetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP),
Indications For Use:
The Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is a single-unit screening test for the rapid detection of two to six of the above drugs in human urine. The designated cutoff concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Tom Coogan
Division Sign-Off
Office of In Vitro Diagnostic Device Page 1 of Evaluation and Safety
510(k) Koyoloz
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).