(69 days)
The Accu-Stat™ Home Drug Test for Marijuana (THC) is a screening test for the rapid detection of THC and its metabolites in human urine at a cut-off level of 50 ng/ml. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.
The Accu-Stat™ Home Drug Tcst for Marijuana and Cocaine (THC, COC) is a screening test for the rapid detection of THC and/or COC and its metabolites in human urine at a cut-off level of 50 ng/ml for THC and 300 ng/ml for COC. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of either THC, COC (or their metabolites) in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.
The Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC), like other commercially available drug screening tests, qualitatively measures the presence or absence of THC and COC 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 Cocaine, if present in the urine specimen below 300 ng/ml, 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 or cocaine 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 50 ng/ml because it will saturate all the binding sites of anti-marijuana antibodies. The same holds true for cocaine if the level is above 300 ng/ml. It will saturate all the binding sites of anti-cocaine 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 two devices, the Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC). It outlines their intended use and claims substantial equivalence to predicate devices, but does not include a detailed study with acceptance criteria and specific performance metrics for the Accu-Stat™ devices themselves.
Instead, the submission states that "The consumer studies using the Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC) 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 and COC."
It further argues for safety and effectiveness by claiming the devices are "identical to the ACON Laboratories One Step Marijuana Test Device and the Multi-Drug Multi-Line Device that is legally marketed under K003557 and K020313 respectively for professional use." This suggests reliance on the predicate devices' performance rather than a new, independent study with specific acceptance criteria reported in this document for the Accu-Stat™ devices.
Therefore, I cannot populate all the requested fields with specific, quantifiable data directly from this document regarding the Accu-Stat™ devices' performance against explicit acceptance criteria. The document claims substantial equivalence and mentions "consumer studies" but does not detail their methodology, results, or the acceptance criteria used.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated for the Accu-Stat™ devices in this document. The document refers to cut-off levels as part of the device's mechanism: "Marijuana, if present in the urine specimen below 50 ng/ml... and Cocaine, if present in the urine specimen below 300 ng/ml, will not saturate the binding sites..." This describes the functional threshold rather than an acceptance criterion for accuracy or precision.
- Reported Device Performance: The document offers a qualitative statement: "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 and COC." No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy percentages) are provided in this text for the Accu-Stat™ devices themselves.
| Acceptance Criterion | Reported Device Performance (Accu-Stat™ Home Drug Test) | Notes |
|---|---|---|
| Not explicitly stated in the provided text. | "Excellent overall performance in the hands of lay users." | This is a qualitative statement, no specific metrics (e.g., sensitivity, specificity, accuracy) are provided for the Accu-Stat™ devices in this submission. |
| Functional Cut-off for THC | Device detects THC at a cut-off level of 50 ng/ml. | This is an operational characteristic, not a performance metric and associated acceptance criterion. |
| Functional Cut-off for COC | Device detects COC at a cut-off level of 300 ng/ml. | This is an operational characteristic, not a performance metric and associated acceptance criterion. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document mentions "consumer studies" but does not quantify the sample size.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document does not describe the establishment of a ground truth for a test set for these specific devices, only mentions that they are "screening tests" and preliminary, requiring confirmation testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as the details of a specific test set study for these devices (beyond "consumer studies") are not provided.
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
- Not applicable. This device is a rapid immunoassay for drug detection, not an AI-assisted diagnostic device, nor does the document describe a study of human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device is a standalone immunoassay kit intended for "lay users" (consumers) at home without professional human-in-the-loop involvement for initial screening. However, the performance data for such standalone use (e.g., accuracy against a gold standard) is not detailed in this document. The instructions advise a second step of confirmation testing by a lab for positive results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified for the "consumer studies." Given the nature of a drug test, a typical ground truth would be laboratory confirmation using a highly accurate method like GC/MS (Gas Chromatography/Mass Spectrometry). The document only states that the device is the "first step in a two-step process to provide over-the-counter (OTC) consumers... with information regarding the presence of THC or COC and their metabolites in a urine sample. Information regarding the second step, confirmation testing, is provided." This implies that the device offers a preliminary result rather than a definitive ground truth.
8. The sample size for the training set
- Not applicable. This device is an immunoassay, not a machine learning or AI-based system that would typically have a "training set."
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
{0}------------------------------------------------
APR 1 9 2004
Section D
510(k) Summary [ As required by 21 CFR 807.92 ]
| Submitter: | |
|---|---|
| A. Name: Accu-Stat Diagnostics, Inc. | |
| B. Address: 11 Orchard Road, Suite # 108, Lake Forest, CA 92630 | |
| Phone 949-916-7560C. Phone and Fax Numbers:949-916-7595Fax | |
| D. Contact Person: James G. Barrons | |
| II. | Date of Preparation of this Summary: 6 February, 2004 |
| III. | Trade Name: Accu-Stat™ Home Drug Test for Marijuana (THC)Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC,COC) |
| IV. | Common Name: At home rapid screening test for Marijuana (THC) in urine.At home rapid screening test for Marijuana & Cocaine(THC, COC) in urine |
| V. | Classification Name: Immunoassay for the qualitative detection of drugs ofabuse in urine. |
| VI. | The Marketed Products to Which Equivalence is claimed: The Accu-Stat™Home Drug Test for Marijuana (THC) is substantially equivalent to theFirst Check® Home Drug Test for THC (Marijuana) and the Phamatech AtHome™ Drug Test for Marijuana. The Accu-Stat™ Home Drug Test forMarijuana and Cocaine (THC, COC) is substantially equivalent to the FirstCheck® Home Drug Test for Marijuana and Cocaine and other commerciallyavailable drug screening tests that qualitatively measure the presence of targetdrugs or metabolites by visual color one-step immunoassay technology. |
| VII. | Statement of Intended Use Compared to Other Products: The intended use ofthe Accu-Stat™ Home Drug Tests for Marijuana (THC) and for Marijuana &Cocaine (THC COC) are substantially equivalent to the above listed products |
Cocaine (THC, COC) are substantially equivalent to the above listed products and are preliminary, rapid screening tests for the detection Marijuana (THC) and Cocaine (COC) and their metabolites in urine. These products are intended to be the first step in a two-step process to provide over-the-counter (OTC) consumers, including but not limited to concerned parents, with information regarding the presence of THC or COC and their metabolites in a urine sample. Information regarding the second step, confirmation testing, is provided.
{1}------------------------------------------------
- Discussion of Technological Characteristics: The Accu-Stat™ Home Drug VIII. Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC), like other commercially available drug screening tests, qualitatively measures the presence or absence of THC and COC 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 Cocaine, if present in the urine specimen below 300 ng/ml, 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 or cocaine 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 50 ng/ml because it will saturate all the binding sites of anti-marijuana antibodies. The same holds true for cocaine if the level is above 300 ng/ml. It will saturate all the binding sites of anti-cocaine 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 multi-drug display. The consumer studies using the Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC) 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 and COC.
- IX. Safety and Effectiveness: Because the Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC) are identical to the ACON Laboratories One Step Marijuana Test Device and the Multi-Drug Multi-Line Device that is legally marketed under K003557 and K020313 respectively 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 or THC & COC and its/their metabolite(s). Because the labeling of the Accu-Stat™
{2}------------------------------------------------
Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC) is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the First Check® Home Drug Test and the Phamatech At Home™ Drug Test, 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}------------------------------------------------
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 9 2004
Mr. James G. Barrons President Accu- Stat Diagnostics, Inc. 11 Orchard Road Suite 108 Lake Forest, CA 92630
K040327 Re:
Trade/Device Name: Accu- Stat™ Home Drug Tcst for Marijuana (THC) Accu-StatTM Home Drug Test for Marijuana and Cocaine (THC.COC) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: MVO, LDJ, DIO Dated: February 6, 2004 Received: February 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 interstatc 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
{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, US, DVM.
Jean 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-1
Indications for Use
510(k) Number (if known): K040327
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Accu-Stat™ Home Drug Test for Marijuana (THC) is a screening test for the rapid detection of THC and its metabolites in human urine at a cut-off level of 50 ng/ml. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Alberto Luti
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 2
510(k) K040322
{6}------------------------------------------------
Section A-2
Indications for Use
510(k) Number (if known): K040327
Accu-Stat™ Home Drug Test for Marijuana and Cocaine (THC, COC) Device Name:
Indications For Use:
The Accu-Stat™ Home Drug Tcst for Marijuana and Cocaine (THC, COC) is a screening test for the rapid detection of THC and/or COC and its metabolites in human urine at a cut-off level of 50 ng/ml for THC and 300 ng/ml for COC. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence or absence of either THC, COC (or their metabolites) in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Alberto Int
Division Sian-
Page 2 of 2 Office of In Vitro Diagnostic Device Evaluation and Safety
530(k) K040237
N/A