(86 days)
The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| PCP | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| РСР | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.
The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
The provided text does not contain detailed information about a study proving the device meets acceptance criteria. It primarily focuses on the regulatory submission, device description, intended use, and substantial equivalence to other devices.
However, based on the context of a drug test, we can infer some general acceptance criteria and what a typical study for such a device would entail. I will use the available information to construct the response, and clearly indicate where assumptions or general knowledge about drug testing device studies are used.
Acceptance Criteria and Device Performance (Inferred/General)
Since this is an immunoassay for drug detection, key performance metrics usually involve sensitivity, specificity, and accuracy against a gold standard method. The document specifies "cut-off concentrations," which are crucial for defining performance.
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/General expectation for this type of device) |
|---|---|
| Sensitivity (Ability to correctly identify positive samples at or above cut-off) | High (e.g., >95% for each drug) |
| Specificity (Ability to correctly identify negative samples below cut-off) | High (e.g., >95% for each drug) |
| Accuracy (Overall agreement with the gold standard) | High (e.g., >95% for each drug) |
| Precision/Reproducibility (Consistency of results) | Consistent results across replicates and different operators. |
| Interference (Lack of interference from common substances) | Minimal interference from common medications or urine adulterants. |
| Cut-off Concentration Performance (Correct detection at specified cut-offs) | Accurate detection at THC: 50ng/mL, PCP: 25ng/mL, Opiates: 2000ng/mL, Cocaine: 300ng/mL, Methamphetamine: 1000ng/mL. |
Study Details (Largely Inferred based on typical drug test validation studies, as specific study details are not provided in the input)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. For a multi-analyte home drug test, test sets typically involve hundreds to thousands of urine samples, covering a range of concentrations around the cut-off (negative, near cut-off, positive). This would include samples spiked with known drug concentrations and potentially clinical samples.
- Data Provenance: Not specified. Typically, studies for such devices involve a mix of spiked samples (known concentrations prepared in a lab) and clinical urine samples collected retrospectively or prospectively from individuals who may or may not have used the drugs. The country of origin for the data is not mentioned but would likely be the USA if the submission is for FDA approval.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable in the traditional sense for drug tests. The "ground truth" is established by a highly sensitive and specific analytical method, not by expert consensus for interpretation of results.
- Qualifications of Experts: Not applicable. The "experts" would be laboratory technicians or chemists operating the confirmatory method (GC/MS).
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Adjudication method for the test set:
- Method: Not applicable. The "ground truth" for drug presence and concentration in urine is determined by a definitive analytical method, most commonly Gas Chromatography/Mass Spectrometry (GC/MS), as explicitly mentioned in the document ("Confirmation, using GC/MS, of any possible drug result is recommended as the second step"). There is no subjective interpretation requiring adjudication of results from the reference method.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
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MRMC Study: Not mentioned and highly unlikely for this type of device. MRMC studies are typically for image-based diagnostics where human interpretation is a primary variable. For a qualitative, visually read immunoassay, the "reader" is usually the end-user (a layperson for a home test) following instructions. The performance is assessed on how accurately the device itself reflects the presence of the drug, not on improved human reading with AI assistance.
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Effect Size of AI vs. without AI assistance: Not applicable, as AI assistance is not described or implied for this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the core "performance" of the Peace of Mind Home Drug Test itself is a standalone assessment. The device is a qualitative immunoassay. The study would assess how well the device, when read according to its instructions (presumably by a human), matches the GC/MS results. While a human reads the test, the performance is inherently of the device's chemical reaction and visual output. The device itself produces the "result" (line or no line), and the human merely observes it.
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The type of ground truth used:
- Type: Analytical Gold Standard (GC/MS - Gas Chromatography/Mass Spectrometry). The document explicitly states: "Confirmation, using GC/MS, of any possible drug result is recommended as the second step." This indicates that GC/MS is the definitive method for validating the presence and concentration of drugs.
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The sample size for the training set:
- Sample Size: Not applicable. Immunoassays are not "trained" in the same way machine learning algorithms are. Their performance is inherent to their chemical design. While development and optimization use various samples, there isn't a "training set" in the sense of AI or statistical modeling.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable for a training set, as there isn't one in the AI sense. During the development and validation phase, ground truth for sample characterization (e.g., preparation of spiked samples to known concentrations, or confirmation of clinical samples) would be established using GC/MS.
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FEB 0 7 2002
510(k) Summary
KU13778
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is:
- Date of summary: November 8, 2001
- aLATEX Scientific Inc. 2. Submitted by: 6355 Westheimer Rd. Suite 105 Houston TX 77057
Peace of Mind Home Drug Test 3. Device Name:
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Device Classification: Class II, Panel 91 Toxicology
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Device description: The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
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Intended Use: The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| PCP | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
- Substantial Equivalence: The Peace of Mind Home Drug Test is substantially equivalent to several other professional and over the counter immunoassay Drugs of Abuse Tests, such as Phamatec QuickScreen™ At Home Test and the Drug Stop Test. These home drug tests are the first of a two-step process to detect the presence or absence of drugs of abuse in human urine and require consumers to confirm possible positive results with GC/MS.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract image of an eagle. The eagle is depicted with three stylized wing strokes and a curved body, symbolizing the department's mission related to health and human welfare. The logo is simple and monochromatic.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 0 7 2002
aLATEX Scientific Inc. c/o Ms. Janis Freestone Director, Regulatory Affairs Advantage Diagnostics Corporation, Ltd. 1201 Douglas Avenue Redwood City, CA 94063
K013778 Re:
Trade/Device Name: Peace of Mind Home Drug Test Regulation Number: 21 CFR 862.3870; 21 CFR 862.3250; 21CFR 862.3610; 21 CFR 862.3640 Regulation Name: Cannabinoid test system; Cocaine and cocaine metabolite test system; Methamphetamine test system; Morphine test system Regulatory Class: Class II; Class II; Class II; Class II; Class II Product Code: MVO; LDJ; DIO; DJC; DPK; LCM Dated: November 12, 2001 Received: November 13, 2001
Dear Ms. Freestone:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I hils letter will anow your of substantial equivalence of your device to a legally marketed nothication. The I Dri Intention for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 II you desire specific active actives), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (301) 594-4500. Traditionally) and eat (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mioritation on your respections.
Manufacturers International Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrfb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K013778 510k Number:
Device Name: Peace of Mind Home Drug Test
Indications for Use:
The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| РСР | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.
Sian Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013778
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Image /page/3/Picture/11 description: The image shows the phrase "Over the counter use" with a symbol next to it. The symbol is a line with an X over it. This symbol is commonly used to indicate that something is not allowed or should not be done. The text and symbol together likely indicate that the product is not intended for over-the-counter use.
N/A