Search Results

The RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device is a lateral flow competitive immunoassay intended for the qualitative detection for the cocaine metabolite, benzoylecgonine, in human urine at a cut-off concentration of 300 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For In Vitro Diagnostic Use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a cocaine metabolite specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

The RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device is an immunoassay based on the principle of competitive binding. The cocaine metabolite, benzoylecgonine, which may be present in the urine specimen competes against its respective drug conjugate for binding sites on the specific antibody. The assay is a colored-latex particle, monoclonal antibody-based rapid test for the qualitative detection of the cocaine metabolite at a cut-off of 300 ng/mL. The test utilizes the QuantRx patented, one step positive read, competitive immunoassay technology.

In the absence of the drug in the urine or if the amount of drug is below cut-off level, the visible test line zone (T) will show a clean negative (no signal on the test band). Drug positive specimens show a blue line in the visible test line zone (T). As an internal procedural control, a red control line appears in the control region (C) to verify that sufficient volume of sample was added and proper flow was obtained. The control line should always appear regardless of the presence of the drug if the assay has been performed properly.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

Note: The document doesn't explicitly state numerical acceptance criteria thresholds. Instead, it presents the performance and concludes that these results "demonstrate the substantial equivalence." The implied acceptance criteria are that the device's performance should be high enough to be considered substantially equivalent to a legally marketed predicate device and to the recognized reference method (GC/MS).

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: 85 specimens
• Data Provenance: "previously collected from subjects presenting for drug testing by an external laboratory." This indicates the data is retrospective. The country of origin is not explicitly stated, but the submission is to the US FDA, suggesting it's likely from the US or a region with comparable clinical practices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The ground truth for the test set (accuracy study) was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided. The ground truth for the test set was established by GC/MS, an objective chemical analysis, not human interpretation requiring adjudication.

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:

This is not applicable. This device is an in-vitro diagnostic (IVD) device (a laboratory test), not an imaging or interpretation device that would involve human readers or AI assistance in the way an MRMC study typically assesses. The device provides a qualitative "positive" or "negative" result.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the accuracy study comparing the RapidSense™ device to GC/MS is a standalone performance study. The device itself, without human interpretation of complex images or data, provides the result directly from the urine sample. Human professionals simply read the yes/no result from the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for the accuracy study was Gas Chromatography/Mass Spectrometry (GC/MS). This is considered a gold standard analytical method for confirming the presence and concentration of drugs and their metabolites in biological samples.

8. The sample size for the training set:

This information is not provided in the document. As an immunoassay, the "training set" concept (as understood for machine learning algorithms) doesn't directly apply in the same way. The device's performance relies on its physical and chemical design, manufacturing, and calibration, rather than an algorithm trained on a dataset.

9. How the ground truth for the training set was established:

This information is not provided and is not directly applicable in the sense of a machine learning training set. The "ground truth" for the development and calibration of such an immunoassay would typically involve testing known positive and negative samples, as well as samples spiked with known concentrations of the analyte, to optimize the assay's sensitivity and specificity around the specified cut-off. This process isn't detailed in the 510(k) summary.

Ask a specific question about this device

The RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device is a lateral flow competitive immunoassay intended for the qualitative detection for Phencyclidine in human urine at a cut-off concentration of 25 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for PCP cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for PCP and cause false positive results.

The RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device is an immunoassay based on the principle of competitive binding. Phencyclidine which may be present in the urine specimen competes against its respective drug conjugate for binding sites on the specific antibody. The assay is a coloredlatex particle, monoclonal antibody-based rapid test for the qualitative detection of Phencyclidine at a cut-off of 25 ng/mL. The test utilizes the QuantRx patented, one step positive read, competitive immunoassay technology.

In the absence of the drug in the urine or if the amount of drug is below cut-off level, the visible test line zone (T) will show a clean negative (no signal on the test band). Drug positive specimens show a blue line in the visible test line zone (T). As an internal procedural control, a red control line appears in the control region (C) to verify that sufficient volume of sample was added and proper flow was obtained. The control line should always appear regardless of the presence of the drug if the assay has been performed properly.

The provided 510(k) summary describes the RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device and a study conducted to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds (e.g., "must achieve >90% sensitivity"). Instead, it presents the device's performance metrics (agreement rates with GC/MS) and implicitly suggests that these results demonstrated "substantial equivalence" to the predicate device and the reference method. For the purpose of this table, I will use the reported agreement rates as the "reported performance" and infer that demonstrating these high levels of agreement was the implicit "acceptance criteria" for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for the Test Set: 80 specimens.
• Data Provenance: The specimens were "previously collected from subjects presenting for drug testing by an external laboratory." This indicates the data is retrospective, and the country of origin is not specified, but given the manufacturer and consultant's addresses are in the US, it's highly likely to be from the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• The ground truth was established by laboratory analysis using Gas chromatography/mass spectrometry (GC/MS). This is an analytical chemical method, not reliant on expert human interpretation in the same way as, for example, a radiologist reading an image. Therefore, the concept of "number of experts" and "qualifications of those experts" as typically applied to clinical image interpretation or diagnosis by multiple clinicians does not directly apply here. The "experts" would be the trained laboratory personnel operating the GC/MS equipment and interpreting the results according to established protocols. No specific number or qualifications are given in the document, which is typical for objective analytical methods.

4. Adjudication Method for the Test Set

• Not applicable in the conventional sense for this type of study. The ground truth was established by GC/MS, which is an objective chemical analysis. The RapidSense™ device results were directly compared to these GC/MS results. There was no mention of multiple readings of the RapidSense™ device that required adjudication.

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 study is for an in vitro diagnostic (IVD) device (a lateral flow immunoassay), not an AI-based diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, this study represents a standalone performance evaluation of the RapidSense™ device. The device itself (a test strip) generates a result (positive or negative read based on a colored line), and this result is directly compared to the GC/MS reference method. While healthcare professionals interpret the visual output, the study focuses on the accuracy of the device's output itself, independent of potential human interpretive errors influencing the device's intrinsic performance.

7. The Type of Ground Truth Used

• The ground truth used was Gas chromatography/mass spectrometry (GC/MS) results. This is considered a gold standard analytical method for confirming the presence and concentration of drugs in urine.

8. The Sample Size for the Training Set

• The document does not provide information regarding a training set. This is typical for traditional immunoassay devices, which are developed based on chemical and biological principles rather than machine learning models that require distinct training sets. The study described is entirely a performance validation on a "test set" or clinical sample set.

9. How the Ground Truth for the Training Set Was Established

• As no training set is mentioned or implied for the development of this device, this question is not applicable. The device's mechanism (competitive immunoassay with colored-latex particles) is based on established biochemical principles, not on learned patterns from a training dataset.

Ask a specific question about this device

The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device is a lateral flow competitive immunoassay intended for the qualitative detection of Methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for methamphetamine cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for methamphetamine and cause false positive results.

The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device is an immunoassay based on the principle of competitive binding. Methamphetamine which may be present in the urine specimen competes against its respective drug conjugate for binding sites on the specific antibody. The assay is a colored-latex particle, monoclonal antibody-based rapid test for the qualitative detection of Methamphetamine at a cut-off of 1000 ng/mL. The test utilizes the QuantRx patented, one step positive read, competitive immunoassay technology.

In the absence of the drug in the urine or if the amount of drug is below cut-off level, the visible test line zone (T) will show a clean negative (no signal on the test band). Drug positive specimens show a blue line in the visible test line zone (T). As an internal procedural control, a red control line appears in the control region (C) to verify that sufficient volume of sample was added and proper flow was obtained. The control line should always appear regardless of the presence of the drug if the assay has been performed properly.

Here's a breakdown of the acceptance criteria and the study details for the RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a predefined numerical target for sensitivity and specificity. Instead, the study aims to demonstrate substantial equivalence to a predicate device (ACON mAMP One Step Methamphetamine Test Strip & Test Device, K011672). The performance metrics presented are the direct results of this comparative study. Therefore, the "acceptance criteria" can be inferred to be a level of agreement with the reference method and comparable performance to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 84 specimens
• Data Provenance: The specimens were "previously collected from subjects presenting for drug testing by an external laboratory." This indicates the data is retrospective and likely originated from a clinical setting where drug testing is performed. The specific country of origin is not explicitly stated but is implied to be within the scope of the "external laboratory."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth was established by Gas chromatography/mass spectrometry (GC/MS), which is an analytical chemical method. Therefore, the "experts" in this context would be the specialized laboratory personnel or analytical chemists who performed and interpreted the GC/MS analysis. The document does not specify the number of individuals involved in performing the GC/MS or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

There was no human "adjudication method" in the sense of multiple human readers independently assessing the results and then resolving discrepancies. The device's results were directly compared against the GC/MS results, which served as the definitive ground truth.

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 conducted. This study focused on the standalone performance of the RapidSense™ device against a gold standard (GC/MS) and a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 device itself is a qualitative immunoassay that provides a visual end point. The reported results (positive, negative, total agreement) are based on the direct interpretation of the device's output, without human-in-the-loop assistance for the device's reading itself. (Human technicians would apply the sample and read the results, but it's the device's intrinsic performance being measured).

7. The Type of Ground Truth Used

The type of ground truth used was analytical/confirmatory method data, specifically Gas chromatography/mass spectrometry (GC/MS). GC/MS is widely considered the gold standard for confirming drug presence and concentration.

8. The Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This is typical for immunoassay devices, where the "training" (development and optimization) of the assay components and format is usually an internal process that occurs before formal validation studies. The reported study focuses on the validation of the finalized device.

9. How the Ground Truth for the Training Set Was Established

As no training set information is provided, there is no detail on how ground truth for any potential training set was established.

Ask a specific question about this device

The QuantRx Female Fertility Test is intended to measure follicle-stimulating hormone (FSH) in urine as an ancillary screen of fertility for home use by women who are attempting to conceive.

The QuantRx Female Fertility Test is a rapid, immunochromatographic assay for the measurement of follicle-stimulating hormone (FSH) in human urine. The test is performed on day 3 of the menstrual cycle by urinating directly on the absorbent tip or by dipping it in a cup of urine, and observing for the formation of colored lines after 10 minutes. A test line of color intensity greater than or equal to the reference line indicates an FSH level of at least 10 mIU/mL is indicative of diminished ovarian reserve, which corresponds to reduced fertility. A test line intensity of less than the reference line is indicative of normal ovarian reserve.

Here's a breakdown of the acceptance criteria and study details for the QuantRx Female Fertility Test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

• Concordance (trained user) between proposed device vs. laboratory method | 89% |
  | - Concordance (layperson) between proposed device vs. laboratory method | 88% |
  | - Concordance trained user vs. layperson for primary study | 98% |
  | Supplemental Study:
• Concordance (trained user) between proposed device vs. predicate | 94% |
  | - Concordance (layperson) between proposed device vs. predicate | 92% |
  | - Concordance trained user vs. layperson for supplemental study | 98% |
  | The device is intended to measure FSH in urine, with a test line intensity equal to or darker than the reference line (calibrated at 10 mIU/mL) indicating FSH ≥ 10 mIU/mL, and a lighter intensity indicating FSH

Ask a specific question about this device