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510(k) Data Aggregation
(90 days)
Phamatech Inc.
The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, oxycodone, buprenorphine and tricyclic antidepressants (imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only.
The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the rapid detection of the following drugs in urine at the cut-off concentrations listed in Table 1. It is a competitive immunoassay that is used to screen for the presence of drugs of abuse in urine. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a single-use device utilizing a cup format.
The device is based upon the Phamatech At Home 12 Drug Test Models 9308Z cleared in K070009 for home use for the detection of amphetamines(AMP), barbiturates (BAR), benzodiazepines (BZD), cocaine (COC), ecstasy (MDMA), methadone (MTD), methamphetamine(MET), opiates (OPI), oxycodone (OXY), phencyclidine (PCP) and marijuana (THC) in urine samples. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z adds testing for tricyclic antidepressants (TCA) (imipramine) and buprenorphine (BUP).
The QuickScreen Pro Multi-Drug Screening Test System is intended for use in prescription point-of-care settings.
The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a chromatographic absorbent device in which drugs or drug metabolites in a urine sample compete with drug / protein conjugate immobilized on a porous membrane of the test device for a limited number of antibody / dye conjugate binding sites. The test device employs a unique combination of monoclonal and polyclonal antibodies to selectively identify drugs of abuse in urine. The test device also contains a self-timer that indicates when test results are ready to be interpreted.
Here's a breakdown of the acceptance criteria and study information for the QuickScreen Pro Multi Drug Screening Test, Model 9395Z, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for the performance characteristics beyond the cut-off concentrations. Instead, it describes the established cut-off concentrations for each analyte and implies that the device's performance (sensitivity/precision) was evaluated against these cut-offs. The study focused on proving substantial equivalence to a predicate device, particularly for the newly added analytes (TCA and BUP).
Therefore, the "acceptance criteria" can be inferred to be the ability of the device to qualitatively detect the analytes in urine at or around the specified cut-off concentrations with acceptable precision/sensitivity. The "reported device performance" is a general statement that the device performs as intended and is substantially equivalent to the predicate for all analytes, with specific studies for TCA and BUP.
| Analyte | Abbreviation | Cut-off Concentration (ng/ml) (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Amphetamines | AMP | 1000 | Performs as intended, substantially equivalent to predicate |
| Barbiturates | BAR | 200 | Performs as intended, substantially equivalent to predicate |
| Benzodiazepines | BZD | 200 | Performs as intended, substantially equivalent to predicate |
| Cocaine | COC | 300 | Performs as intended, substantially equivalent to predicate |
| Ecstasy | MDMA | 500 | Performs as intended, substantially equivalent to predicate |
| Methadone | MTD | 300 | Performs as intended, substantially equivalent to predicate |
| Methamphetamine | MET | 500 | Performs as intended, substantially equivalent to predicate |
| Opiates | OPI | 300 | Performs as intended, substantially equivalent to predicate |
| Oxycodone | OXY | 100 | Performs as intended, substantially equivalent to predicate |
| Phencyclidine | PCP | 25 | Performs as intended, substantially equivalent to predicate |
| Marijuana | THC | 50 | Performs as intended, substantially equivalent to predicate |
| Tricyclic Antidepressants | |||
| (Imipramine) | TCA (Imipramine) | 1000 | Performance testing conducted, performs as intended |
| Buprenorphine | BUP | 10 | Performance testing conducted, performs as intended |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the test sets for each type of performance study (Method Comparison, Assay Interference, Assay Precision/Sensitivity, Prozone Response, Sample pH, Read Time, Sample Temperature, Specific Gravity).
Data provenance is not explicitly stated regarding country of origin; however, the manufacturer is Phamatech, Inc. in San Diego, CA, suggesting the studies were likely conducted in the US. The studies are prospective in nature, as they involve testing the device to demonstrate its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. For a drug screening test, the ground truth is typically established by analytical methods (like GC/MS) or by spiking urine samples with known concentrations of analytes.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method by human readers for the test set. For a qualitative immunoassay, the result is read directly from the test lines (presence or absence), and the comparison is to the confirmed analytical result.
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
No MRMC comparative effectiveness study was done, nor does the document describe any AI component to the device. This is a point-of-care, qualitative immunoassay designed for direct interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is not an algorithm-only device. It is a physical immunoassay kit that produces a visual result. The "standalone" performance would refer to the device itself providing a result that is then compared to an analytical standard, which is implied by the performance studies (e.g., precision/sensitivity). There are no "human-in-the-loop" aspects in terms of interpretation algorithms to evaluate.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this type of device is established by analytical methods, specifically by preparing urine samples with known concentrations of the analytes (e.g., using fortified samples at various concentrations around the cut-off) and comparing the device's results to these known concentrations, or by confirming positive results with a gold standard like Gas Chromatography/Mass Spectrometry (GC/MS). The document states, "Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method," indicating this is the expected ground truth for confirmation.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This is common for immunoassay devices, where performance is typically established through analytical validation studies rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described for a machine learning algorithm, the concept of establishing ground truth for a training set does not apply here. The device's performance is validated against analytical standards and comparative methods.
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(392 days)
PHAMATECH INC.
QuickScreen™ Amphetamine 500 Test Model 9058 (dip card): The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
QuickScreen™ Amphetamine 500 Test Model 9054 (cassette): The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Amphetamine in urine. The cut-off concentration is 500 ng/ml. It is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
QuickScreen ™ Multi Drug Screening Test Model 9346T(dip card): The QuickScreen™ Multi Drug Screening Test Model 9346T is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinquish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
QuickScreen™ Drug Cup Model 9346Z: The QuickScreen™ Drug Cup Model 9346Z is an in vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, oxycodone, PCP, barbiturates, benzodiazepines, methadone and THC in urine at the cut-off concentrations listed below. The test is available in any combination of the drugs or drug metabolites listed below. Tests for barbiturates, benzodiazepine and oxycodone cannot distinguish between abused drugs and certain prescribed medications. The test is intended for prescription point of care use only. This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, Opiates and Methamphetamine in urine. The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It doesn't typically contain detailed "acceptance criteria" in the sense of predefined thresholds for performance metrics. Instead, it presents performance data to show the new device performs similarly to the predicate device and is safe and effective for its intended use. The "acceptance criteria" can be inferred from the reported performance meeting the generally understood expectations for such devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that explicit formal acceptance criteria are not stated in the document, I will infer them based on the context of drug screening tests and the data presented. The primary acceptance criteria for a qualitative drug screening test revolve around its ability to accurately identify positive and negative samples relative to a confirmatory method, especially around the cutoff concentration.
Device: QuickScreen Drug Screening Test System (specifically for Amphetamine 500 ng/ml cutoff)
| Performance Metric (Inferred Acceptance Criterion) | Reported Device Performance (Amphetamine 500 ng/ml) |
|---|---|
| Sensitivity / Precision (Qualitative Agreement around Cutoff): | |
| Accurately identify negative samples below cutoff. | |
| Accurately identify positive samples above cutoff. | Negative samples: |
| All samples at 100.86 ng/ml, 211.2 ng/ml, 286.22 ng/ml tested negative (60/60 for multi-card, cassette, cup; 80/80 for dipcard at 100.86 ng/ml; 60/60 for dipcard at other concentrations). | |
| Positive samples: | |
| All samples at 583.3 ng/ml, 878 ng/ml, 1062 ng/ml, 1361 ng/ml tested positive (60/60 for all formats and concentrations). | |
| Method Comparison (Clinical Sample Agreement with GC/MS): | |
| High concordance with GC/MS for both positive and negative samples, particularly near the cutoff. | |
| Minimize false positives and false negatives. | Overall Agreement: |
| For samples above cutoff, the device correctly identified all as positive (22 samples in "Cutoff to +50%" and 20 in "High Positive" categories for all formats). | |
| For samples below cutoff, the device correctly identified all as negative (23 samples in "Negative: NO DRUG" and 19 in "Negative |
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(450 days)
PHAMATECH INC.
The QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites in urine. This assay is intended to assist in the prevention of drug abuse. The QuickScreen Drug Screening Test System is for in-vitro diagnostic use and is intended for use in point-of-care settings.
The QuickScreen Cocaine 150 Test is an in-vitro diagnostic test for the detection/presence of cocaine (benzoylecgonine) in urine. The cut-off concentration is 150 ng/ml. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.
An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone , oxycodone and THC in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.
The QuickScreen Drug Screening Test system, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.
The Phamatech QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of various drugs or their metabolites in urine. This analysis focuses on the performance studies for the change to a 150 ng/ml cutoff concentration for cocaine (benzoylecgonine).
1. Acceptance Criteria and Reported Device Performance for Cocaine (150 ng/ml cutoff)
The acceptance criteria for the device performance are implicitly demonstrated by the reported agreement percentages with GC/MS results and the precision at various concentrations around the cutoff. While explicit numerical acceptance criteria are not stated as "thresholds," the reported performance values are presented to demonstrate substantial equivalence to predicate devices.
| Category | Acceptance Criteria (Implicit) | Reported Device Performance (Cocaine 150 ng/ml cutoff) |
|---|---|---|
| Clinical Sample Correlation (Agreement with GC/MS) | High agreement percentage with GC/MS results for both positive and negative samples, particularly around the cutoff. | Dipcard: 98.75% agreement for positive results, 100% agreement for negative results. |
| Cassette: 98.75% agreement for positive results, 100% agreement for negative results. | ||
| Cup: 98.75% agreement for positive results, 100% agreement for negative results. | ||
| Multi-dip: 97.5% agreement for positive results, 100% agreement for negative results. | ||
| Precision around Cutoff | Consistent and accurate detection of positive samples above the cutoff and negative samples below the cutoff. | At Cutoff (150 ng/ml): |
| Multi Card: 12 positive, 68 negative | ||
| Cup: 21 positive, 59 negative | ||
| Cassette: 15 positive, 65 negative | ||
| At 125% of Cutoff (187.5 ng/ml): 100% positive detection across all formats. | ||
| At 75% of Cutoff (112.5 ng/ml): 100% negative detection across all formats. | ||
| Other Technical Performance Tests | Acceptable results for interference, lot-to-lot consistency, prozone response, and environmental factors. | "Other technical performance tests include: Assay Interference - Negative base, Assay Interference – Positive base, Lot to Lot Consistency, Prozone Response, Effect of Sample pH, Test Strip Dip Time Flex, Read Time Flex, Sample Temperature Flex, Specific Gravity Effects, Format Equivalency." (Results not detailed in provided text, but implied as acceptable). |
2. Sample Size and Data Provenance for Test Set
- Sample Size:
- Method Comparison (Clinical Samples): 80 unaltered clinical urine samples were tested.
- Precision around Cutoff (Spiked Samples): For each concentration level (Negative, -75%, -50%, -25%, Cutoff, 125%, 150%, 175%, 200%), samples were tested across 3 sites by 3 technicians for 20 days. The number of individual tests per concentration can be inferred. For example, at "Cutoff", 80 tests were performed (e.g., 20 days * 3 technicians * X number of tests per technician per day, or a total of 80 combined tests). The provided table lists a total of 80 observations (e.g., 12 pos + 68 neg = 80 for "Multi Card" at cutoff). This implies a total of 80 tests per concentration per format.
- Data Provenance:
- Clinical Samples: Described as "unaltered clinical urine samples." The country of origin is not explicitly stated, but the submission is to the FDA in the USA, implying potential origin from the USA.
- Spiked Samples: "Standard drug solutions diluted in drug free urine." These are laboratory-prepared samples.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: For the method comparison study, "3 operators who are typical operators at this site" performed the tests on the QuickScreen devices.
- Qualifications of Experts: Their specific qualifications (e.g., years of experience, professional titles) are not detailed beyond "typical operators at this site."
- Ground Truth Qualification: The primary ground truth for the clinical samples was established by GC/MS results, which is a gold standard analytical method.
4. Adjudication Method for the Test Set
The adjudication method for the test set is not explicitly described in the provided text. The method comparison states that the 80 clinical samples were "blinded and sufficiently randomized and compared to GC/MS results." This indicates a direct comparison to the GC/MS reference, rather than an adjudication process between human readers or between a human reader and AI.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study evaluates the performance of human readers with and without AI assistance. The QuickScreen Drug Screening Test System is an immunoassay device, not an AI-driven imaging or diagnostic software that assists human readers.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was done. The entire performance evaluation described in the document, including the clinical sample correlation study and the precision studies, represents the standalone performance of the QuickScreen device itself, without human interpretation in a diagnostic workflow (beyond the initial visual reading for qualitative results). The agreementpercentages and precision values directly reflect the device's ability to detect the analytes.
7. Type of Ground Truth Used
- Clinical Samples: The ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered the confirmatory method and the "gold standard" for drug testing.
- Spiked Samples: The ground truth for the precision studies was based on the known concentrations of standard drug solutions diluted in drug-free urine.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI development. The QuickScreen device is a lateral flow immunoassay. Thus, there is no AI algorithm that requires a separate training set. The performance studies mentioned are for validation of the chemical assay.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of AI for this immunoassay device, this question is not applicable. The device's underlying chemical principles are developed and validated, not "trained" on data samples.
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(338 days)
PHAMATECH INC.
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(331 days)
PHAMATECH INC.
The QuickScreen™ Barbiturates Test is a rapid, qualitative immunoassay for the detection of Barbiturates in urine. The cutoff concentration for this test is 300 ngdomly This assay is intended for professional use.
QuickScreen Multi Drug Screening Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: Amphetamine; 1000 ng/ml Barbiturates: 300 nq/ml Benzodiazepines: 200 na/ml Cocaine; 300 ng/ml Methadone 300 nq/ml Methamphetamine; 1000 ng/ml Opiates: 2000 ng/ml. Phencyclidine (PCP) 25 ng/ml THC: 50 nq/ml This assay is intended to assist in the prevention of drug abuse
The QuickScreen Barbiturates Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Barbiturates in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. The cut-off concentration will be 300 ng/ml (secobarbital). It is intended for professional use only.
An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. Tests for prescription drugs cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.
Immunoassay for the qualitative detection of Barbiturates in urine
Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Opiates and Methamphetamine in urine
The Phamatech QuickScreen™ Barbiturates Test (Models 9019, 9018) and the QuickScreen Multi Drug Screening Test (Models 9317T and 9187Z) are qualitative immunoassays for the detection of drugs/drug metabolites in urine. This summary addresses the performance of both devices as described in the provided 510(k) summaries.
Acceptance Criteria and Device Performance
The acceptance criteria for the QuickScreen™ Barbiturates Test and the QuickScreen Multi Drug Screening Test are implied through their claims of substantial equivalence to predicate devices and established laboratory methodologies. The performance is assessed by correlation studies against these benchmarks.
For QuickScreen™ Barbiturates Test:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to commercially available predicate devices (e.g., ABMC RapidOne BZD test) | 97.9% correlation when compared to the predicate devices. |
For QuickScreen Multi Drug Screening Test:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to Behring EMIT II and GC/MS methodology | >98% correlation when compared to Behring EMIT II and GC/MS. |
| Excellent overall accuracy in the hands of professional users | >97% overall accuracy. |
Study Details
The information provided covers both the QuickScreen™ Barbiturates Test and the QuickScreen Multi Drug Screening Test. The studies performed were clinical sample correlation studies and blind labeled spiked studies.
1. Sample Size and Data Provenance:
- QuickScreen™ Barbiturates Test: The number of clinical samples used for the correlation study is not specified, only that "clinical specimens" were used. The country of origin for the data is not explicitly stated, but the manufacturer is based in San Diego, California, USA. The studies appear to be retrospective as they involve evaluating existing samples or spiked samples.
- QuickScreen Multi Drug Screening Test: The number of clinical samples, urine samples, and the specific composition of the blinded spiked samples is not specified. Clinical studies were performed at two independent laboratories. The country of origin for the data is not explicitly stated, but the manufacturer is based in San Diego, California, USA. The studies appear to be retrospective as they involve evaluating existing samples or spiked samples.
2. Number of Experts and Qualifications:
- The 510(k) summaries do not specify the number of experts or their qualifications for establishing ground truth for the test sets. The tests are intended for "professional use," and the Multi Drug Screening Test exhibited "excellent overall accuracy (>97%) in the hands of professional users," implying that professionals (likely lab technicians or clinicians) performed the assessments for the device.
3. Adjudication Method:
- The 510(k) summaries do not describe an adjudication method. The clinical sample correlation studies compare the device's results directly against predicate devices (Barbiturates Test) or Behring EMIT II and GC/MS methodology (Multi Drug Screening Test). The "blind labeled spiked study" implies that the labels of the spiked samples were not known to the testers.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was explicitly mentioned. The studies focus on the device's performance against reference methods rather than comparing human reader performance with and without AI assistance. The devices are point-of-care immunoassay tests, not AI-assisted diagnostic tools requiring human interpretation.
5. Standalone Performance (Algorithm Only):
- Yes, performance was evaluated in a standalone manner. These are immunoassay devices that provide a qualitative result directly, without requiring human interpretation other than observing a visual color change. The reported correlations and accuracy reflect the device's direct output.
6. Type of Ground Truth Used:
- QuickScreen™ Barbiturates Test: The ground truth for the clinical sample correlation study was established by predicate devices (e.g., ABMC RapidOne BZD test). For the blind labeled spiked study, the ground truth was based on the known concentrations of barbiturates in the spiked samples.
- QuickScreen Multi Drug Screening Test: The ground truth for the clinical sample correlation study was established by Behring EMIT II and Gas Chromatography/Mass Spectrometry (GC/MS) methodology. For the blind labeled spiked study, the ground truth was based on the known concentrations of the target drugs/metabolites in the spiked samples. GC/MS is widely considered a gold standard for drug confirmation. Expert opinion is also subtly implied through the requirement for professional use and clinical consideration.
7. Sample Size for Training Set:
- The 510(k) summaries do not mention a specific training set or its sample size. These devices are immunoassay tests, not machine learning algorithms that typically require a distinct training set. The development and optimization of such tests usually involve laboratory experiments rather than data-driven training as understood in AI/ML contexts.
8. How Ground Truth for Training Set Was Established:
- As there's no mention of a traditional "training set" in the context of an AI/ML algorithm, this question is not directly applicable. The performance characteristics were evaluated through the clinical sample correlation and blind labeled spiked studies, which served to validate the device's accuracy against established methods and known concentrations.
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(58 days)
PHAMATECH INC.
The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with changes in menopause. This kit provides a preliminary screening result. This kit is intended for over-the-counter sales.
Immunoassay for the qualitative detection of FSH in urine.
Here's an analysis of the provided information regarding the Moments Menopause Check (Model 9113), focusing on its acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance for Moments Menopause Check (Model 9113)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative detection of FSH in urine. | The device performs qualitative detection of FSH in urine. |
| Minimum detectable concentration for FSH is 25 mIU/ml. | The minimum detectable concentration for this test is 25 mIU/ml. |
| Substantially equivalent to predicate devices for qualitative detection of FSH. | "Laboratory studies, using clinical specimens, produced a >98% correlation when compared to the predicate devices." |
| Excellent overall accuracy for consumer interpretation. | "Consumer interpretation of the FSH test showed accuracy to be greater than 98%." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size used for the clinical sample correlation study or the blind labeled spiked study.
- Data Provenance: The studies used "clinical specimens." The country of origin for the data is not specified, but the manufacturer is Phamatech, located in San Diego, California, USA. The studies appear to be prospective, as they were conducted to evaluate the performance of the Moments Menopause Check.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the performance studies.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being performed to assess how much human readers improve with AI vs. without AI assistance. This device is a rapid, qualitative immunoassay for over-the-counter use, and such a study design is generally not applicable to this type of diagnostic.
6. Standalone Performance Study
A standalone performance study was performed. The "clinical sample correlation study" and "blind labeled spiked study" evaluated the device's performance (qualitative detection of FSH in urine) independently. The "consumer study" also assessed the device in a standalone context, focusing on user interpretation.
7. Type of Ground Truth Used
- Clinical Sample Correlation Study: The ground truth for this study was likely established by the "predicate devices" to which the Moments Menopause Check was compared. This implies a comparison to existing, legally marketed FSH tests which themselves have established accuracy.
- Blind Labeled Spiked Study: For this study, the ground truth would have been based on known, controlled concentrations of FSH that were "spiked" into samples, allowing for a direct assessment of the device's ability to detect FSH at the specified threshold (25 mIU/ml).
- Consumer Study: The ground truth for the consumer interpretation was likely derived from the objective results of the FSH test (e.g., whether FSH was actually present at the detectable level) and then compared to the consumer's visual interpretation.
8. Sample Size for the Training Set
The document does not provide information about a training set since this is a chemical test (immunoassay) and not a machine learning or AI-based device. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here. The device's performance is based on its inherent chemical properties and design.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, the concept of a training set and its ground truth is not applicable to this device, which relies on immunoassay technology rather than machine learning.
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(95 days)
PHAMATECH INC.
The QuickScreen™ Oxycodone Test is a rapid, qualitative immunoassay for the detection of Oxycodone in urine. The cutoff concentration for this test is 100 ng/mL.. This test is intended for professional use.
This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
Immunoassay for the qualitative detection of Oxycodone in urine. The QuickScreen™ Oxycodone Test, like many commercially available oxycodone screening test kits, qualitatively measures the presence of oxycodone by visual color sandwich one step immunoassay technology. These devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibodv / target analyte / antibody / complexes.
The provided text describes the 510(k) summary for the QuickScreen™ Oxycodone Test. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format (e.g., Sensitivity > X%, Specificity > Y%). However, it makes a general claim of substantial equivalence.
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate devices | >99% correlation when compared to predicate devices in laboratory studies using clinical specimens. |
| Qualitative immunoassay for detection of oxycodone in urine at a cutoff concentration of 100 ng/ml. |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- Sample Size: Not explicitly stated as a number of samples. It mentions "clinical sample correlation study" and "laboratory studies, using clinical specimens."
- Data Provenance: "clinical sample correlation study" and "laboratory studies, using clinical specimens." No specific country of origin is mentioned, but the manufacturer is based in San Diego, California, USA, suggesting a US context. The study is retrospective given "clinical specimens" would imply pre-existing samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text. The study compares the QuickScreen™ Oxycodone Test to "predicate devices," implying the predicate device's results were used as a reference, but no information on how the predicate device's results themselves were adjudicated is given.
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
No, an MRMC comparative effectiveness study was not done. This device is an immunoassay for drug detection, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a rapid, qualitative immunoassay designed for "professional use," which implies a human in the loop for interpretation of the visual color change. However, the performance reported (" >99% correlation") likely refers to the intrinsic performance of the test strip itself against a reference method or predicate, acting as a standalone evaluation of the device's accuracy in detecting the analyte. It's an "algorithm only" in the sense that the test strip is a chemical algorithm.
7. The Type of Ground Truth Used
The ground truth for the "clinical sample correlation study" and "laboratory studies, using clinical specimens" appears to be the results obtained from predicate devices (e.g., ABMC RapidOne Oxycodone test) and likely a confirmatory analytical method mentioned later as the "preferred confirmatory method" once a preliminary positive result is obtained (Gas chromatography/mass spectrometry (GC/MS)). The statement "A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method" suggests that these methods serve as the ultimate ground truth.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This device is an immunoassay, not a machine learning model that typically requires separate training data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this information is not applicable and hence, not provided.
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(43 days)
PHAMATECH INC.
The QuickScreen™ Benzodiazepines Test is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine. The cutoff concentration for this test is 200 ng/ml. This assay is intended for professional use.
The QuickScreen Benzodiazepines Test is an in-vitro diagnostic screen that provides a qualitative detection of benzodiazepines in urine. It is intended for professional use only.
An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, benzodiazepines, barbiturates, methadone and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.
Immunoassay for the qualitative detection of Benzodiazepines in urine
The QuickScreen™ Benzodiazepines Test, like many commercially available oxycodone screening test kits, qualitatively measures the presence of benzodiazepines by visual color sandwich one step immunoassay technology. These devices rely on the basic immunochemical sandwich assay principle of recognition of specific antibody / target analyte / antibody / complexes.
The Phamatech QuickScreen™ Benzodiazepines Test (Models 9025, 9026, 9027T, 9153 and 9195X) is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine, with a cutoff concentration of 200 ng/ml. The device's performance was evaluated through a clinical sample correlation study and a blind labeled spiked study.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to commercially available tests for qualitative detection of benzodiazepines in urine. | 97.9% correlation when compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "clinical sample correlation study" and "blind labeled spiked study" but does not provide the exact number of samples used in either study.
- Data Provenance: The document states "Laboratory studies, using clinical specimens," which implies the data is from prospective clinical samples. The country of origin is not specified but given the manufacturer (Phamatech, San Diego, California, USA) and the FDA filing, it's highly likely to be from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The study compared the device's performance against "predicate devices," suggesting the predicate device's results were used as the reference or "ground truth," rather than expert adjudication of the samples themselves.
4. Adjudication Method for the Test Set
- None explicitly described in terms of expert adjudication. The study design indicates a comparison to "predicate devices," implying the results generated by these established devices served as the reference standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a qualitative immunoassay for drug detection, where the reading is typically a direct visual interpretation (e.g., presence or absence of a line) and not subject to the same kind of reader variability or interpretation as imaging studies.
- Therefore, the effect size of how much human readers improve with AI vs without AI assistance is not applicable to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance reported is inherently standalone. The QuickScreen™ Benzodiazepines Test is a single-step immunoassay that provides a visual qualitative result. The reported 97.9% correlation is the performance of the device itself (algorithm/assay only) when compared to predicate devices. There is no "human-in-the-loop" aspect to its core diagnostic function; the human merely reads the visual output.
7. The Type of Ground Truth Used
- The ground truth used was the results from predicate devices. The study achieved a "97.9% correlation when compared to the predicate devices." This implies that the performance of existing, legally marketed benzodiazepine screening tests was used as the reference standard against which the QuickScreen™ Benzodiazepines Test was evaluated.
8. The Sample Size for the Training Set
- This information is not provided in the document. As an immunoassay, the device itself doesn't typically undergo "training" in the sense of machine learning algorithms. Its design and manufacturing are established, and then its performance is validated.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as the device is not an AI/machine learning algorithm requiring a "training set" with established ground truth. Its performance characteristics are inherent to its chemical and biological design.
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(77 days)
PHAMATECH INC.
The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with stages in menopause. This kit provides a preliminary result for the detection/presence of FSH in urine. It is intended for over-the-counter sales.
Immunoassay for the qualitative detection FSH (follicle stimulating hormone) in urine. The Moments Menopause Check, like many commercially available FSH screening test kits, qualitatively measures the presence of FSH by visual color sandwich one step immunoassay technology.
Here's a summary of the acceptance criteria and study details for the Moments Menopause Check device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Correlation to Predicate Devices | 98% correlation | Clinical sample correlation study |
| Overall Accuracy (Lay Users) | 97% accuracy | Consumer study |
2. Sample Sizes Used for the Test Set and Data Provenance
The exact sample sizes for the clinical sample correlation study and the consumer study are not explicitly stated in the provided text.
- Data Provenance: The text indicates "Laboratory studies, using clinical specimens" and "A consumer study was also performed." This implies that the data was collected from human participants, likely in a prospective manner for the consumer study, and potentially retrospective or prospective for the clinical sample correlation study, though this is not specified. The country of origin is not mentioned, but the manufacturer is based in San Diego, California, USA, suggesting the studies likely originated there.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Clinical Sample Correlation Study: The "predicate devices" were used as the comparison for establishing ground truth. The expertise involved in generating results from the predicate devices is not specified, but it's implied that these are established, commercially available tests.
- Consumer Study: The ground truth for the consumer study's accuracy (97%) is not explicitly described in terms of "experts." It refers to the device's accuracy in the hands of lay users, suggesting the "truth" against which their results were compared was likely derived from the established laboratory methods (predicate devices) on the same samples, although this is inferred.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated in the provided text for either study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The studies focus on comparing the device to predicate devices and assessing accuracy with lay users, not on how human readers' performance improves with or without AI assistance. The device itself is a qualitative immunoassay, not an AI-assisted diagnostic.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance was done. The "clinical sample correlation study" and the "consumer study" directly assess the performance of the Moments Menopause Check device itself (the "algorithm" in this context refers to the device's inherent detection mechanism) without explicit human-in-the-loop assistance influencing the detection mechanism itself, beyond the user performing the test.
7. Type of Ground Truth Used
- Clinical Sample Correlation Study: The ground truth was established by comparison to predicate devices. This implies the results from established, commercially available FSH screening test kits were considered the "truth."
- Consumer Study: The ground truth for the accuracy assessment against the lay user's results was likely established by laboratory methods (predicate devices) on the same samples, though this is not explicitly stated.
8. Sample Size for the Training Set
The provided text does not mention a training set or its sample size. This type of immunoassay device typically does not involve a "training set" in the machine learning sense. Performance is established through validation studies.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for this type of device, this question is not applicable.
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(21 days)
PHAMATECH INC.
The Phamatech At Home Ovulation Test is a rapid qualitative test for the detection of luteinizing hormone (LH) in urine. The cut-off concentration for this test is as follows: LH at 30mlU/mL. This assay is intended for use in the home to assist in determining the ovulation cycle. The Phamatech At Home Ovulation Test is intended for over the counter use.
Immunoassay for the qualitative detection of LH in urine. The At HOME OVULATION TEST, like many commercially available ovulation test kits, qualitatively measures the presence of luteinizing hormone by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / LH / colored (labeled) antibody complexes.
The Phamatech At HOME OVULATION TEST (Model 9032) is a rapid, qualitative immunoassay for the detection of luteinizing hormone (LH) in urine at a cut-off concentration of 30mlU/mL. It is intended for home use to assist in determining the ovulation cycle.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with predicate device (Syntron Be Sure Test) | >99% correlation in clinical sample correlation study |
| Overall accuracy in professional hands | >98% overall accuracy in clinical studies at two independent laboratories |
| Overall accuracy in consumer hands | "Excellent overall accuracy" (specific percentage not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample sizes for the clinical sample correlation study, the clinical studies with professional users, and the consumer study are not explicitly stated in the provided document. The data provenance is described as "clinical specimens" and "clinical studies, performed at two independent laboratories," suggesting that the data is prospective and likely collected in a clinical setting. The country of origin of the data is not specified, but the manufacturer is based in San Diego, California, USA, implying the studies were likely conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions "professional users" in clinical studies, but their role in establishing ground truth versus simply performing the test is unclear.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on the device's accuracy and correlation, not on comparing human reader performance with and without AI assistance. This device is a rapid diagnostic test, not an AI-driven image analysis tool.
6. Standalone Performance
Yes, standalone performance (algorithm only performance, without human-in-the-loop) was assessed. The "At HOME OVULATION TEST" is a standalone device that provides a visual result directly to the user, the manufacturer or a professional user would determine the performance data as reported above, but also included in this filing is consumer user performance. The device's performance metrics (correlation, overall accuracy) reflect its inherent ability to detect LH. The "consumer study" further assesses its standalone performance when interpreted by lay users.
7. Type of Ground Truth Used
The ground truth for the clinical sample correlation study was established by comparing the At HOME OVULATION TEST results to the Syntron Be Sure Test, a predicate device. For the clinical studies and consumer study, the ground truth would typically be established through established laboratory methods or medical assessment of the individual's LH levels, though the exact method is not detailed in the provided document. Given it's an ovulation test, the ground truth for LH levels would likely be based on quantitative immunoassay results or other accepted methods for measuring LH in urine.
8. Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. This device relies on "basic immunochemical sandwich assay principle," not on machine learning or AI models that require specific training sets.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML model, there is no information on how its ground truth was established.
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