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The Redi-Screen is a qualitative, one step, immunochromatographic competitive assay for the qualitative determination of the presence of THC, Phencyclidine, Opiates, Cocaine and Methamphetamine at the following cut off concentrations;

The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.

This test is for use in clinical laboratories by health care and forensic professionals only.

The Redi-Screen is an immunochromatographic based one step in vitro test.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Redi-Screen device:

It's important to note that the provided text is a 510(k) Summary and an FDA clearance letter, which typically do not contain detailed clinical study reports. Therefore, much of the requested information (like sample sizes for test sets, expert qualifications, adjudication methods, multi-reader studies, and training set details) is not present in this document. The focus here is on demonstrating substantial equivalence to a predicate device based primarily on analytical performance, not extensive human-in-the-loop clinical assessments.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for this device are established by its functionality as a qualitative screening test for specific drugs of abuse (DOA) at defined cut-off levels. The "reported device performance" is essentially that it achieves these cut-off levels and is substantially equivalent to existing individual tests.

Table of Acceptance Criteria and Reported Device Performance:

Summary of Study to Prove Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is framed as a Substantial Equivalence comparison to five existing, legally marketed predicate devices (Redi-THC, Redi-PCP, Redi-Cocaine, Redi-Opiates, and Redi-Methamphetamine).

The document states:

"The Redi-Screen was found substantially equivalent to the five single tests for the individual DOA. i.e., the Redi-THC. Redi-PCP. Redi-Cocaine. Redi-Opiates and Redi-Methamphetamine. All products are immunoassays and use specific antibodies to detect various drug compounds. Both predicate and modified tests are preliminary screens for human urine and require confirmation with alternate methods such as GC/MS. The sensitivity for the Redi Screen is equivalent to the single tests."

This indicates that the Redi-Screen's ability to detect the specified drugs at or above the cut-off levels was deemed equivalent to the established performance of the predicate devices. This equivalence implies that the Redi-Screen effectively meets the analytical performance "acceptance criteria" defined by these cut-off levels, consistent with other similar immunoassay screening tests.

Detailed Information (Based on available text):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not specified in the provided text. The document focuses on the type of comparison (substantial equivalence) rather than the detailed methodology and sample sizes of the underlying analytical studies. Urine specimens are mentioned, but no specifics on quantity or origin.

2. 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 applicable/Not specified. For an in-vitro diagnostic (IVD) immunoassay like this, "ground truth" is typically established by objective analytical methods (e.g., GC/MS or comparison to known standards/controls) rather than expert consensus on images or clinical cases. The document mentions "clinical laboratories by health care and forensic professionals," but this refers to the users of the test, not experts establishing ground truth for a study.

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

   • Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where there's human interpretation involved and potential for disagreement. This is an IVD device, where the output is a qualitative (positive/negative) result based on a chemical reaction.

4. 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. This is an in-vitro diagnostic device, not an AI-assisted diagnostic imaging or clinical decision support tool. MRMC studies are not relevant here.

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

   • Yes, in essence. The Redi-Screen is a standalone immunoassay device. Its performance is evaluated based on its ability to detect the target substances in a sample, independent of human interpretation beyond reading the visual bands. While a human reads the result, the "performance" described (detection at cut-off) is of the device itself.

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

   • The "ground truth" for this type of device is typically established by confirmed analytical methods, most commonly Gas Chromatography/Mass Spectrometry (GC/MS). The intended use statement explicitly supports this: "The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS." This implies that GC/MS would be the gold standard for confirming the presence and concentration of the drugs.

7. The sample size for the training set:

   • Not applicable/Not specified. This is an immunoassay, not a machine learning model that requires a "training set" in the conventional sense. The "training" for such devices involves assay development, optimization, and characterization studies, not data-driven model training.

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

   • Not applicable/Not specified. As there's no machine learning training set, this question is not relevant. The "ground truth" for developing and validating the assay's performance would be derived from known-concentration controls and samples confirmed by reference methods like GC/MS.

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The Redi-Screen is designed for the qualitative determination of five (5) DOA and their metabolites in human urine specimens. The five DOA include THC, PCP, Opiates, Cocaine and Methamphetamine. The presence of these drugs and their cross-reacting metabolites in human urine can be detected above the following cut off levels:

THC 50ng/mL
PCP 25ng/mL
Opiates 300ng/mL
Cocaine 300ng/mL
Methamphetamine 1,000ng/mL

The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS,

This test is for use in clinical laboratories by health care and forensic professionals only.

The Redi-Screen is an immunochromatographic based one step in vitro test.

Here's a breakdown of the acceptance criteria and the study information for the Redi-Screen 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 pass/fail threshold for the device's performance compared to a gold standard. Instead, it describes comparison studies that show the device's agreement with predicate devices. The "acceptance criteria" here implicitly refers to showing substantial equivalence.

Note: The agreement percentage is a range provided for "all aspects" of the comparison studies against commercially available EIA DOA tests, not specific to each analyte.

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

• Sample Size for Test Set: Not explicitly stated. The document only mentions "comparison studies" and "precision studies."
• Data Provenance: Not explicitly stated. Given it's a submission to the FDA for a device intended for clinical laboratories, it's likely the data was collected in a controlled laboratory setting, but the country of origin is not specified, nor whether it was retrospective or prospective.

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

Not applicable. This device is an in-vitro diagnostic (IVD) for drug screening. Ground truth for such devices is typically established through analytical methods like GC/MS, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this isn't a device that requires human expert adjudication for establishing ground truth. The confirmation method is "alternate methodology, preferably GC/MS."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is an in-vitro diagnostic device and does not involve human readers interpreting results in the way an imaging AI would. Therefore, an MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, essentially. The Redi-Screen is a standalone immunochromatographic test. Its performance is evaluated intrinsically through comparison studies, precision studies, specificity, and validation of cut-offs. It provides "only a preliminary analytical result," indicating it operates independently to provide that result, which then requires external confirmation (GC/MS).

7. The Type of Ground Truth Used:

The primary "ground truth" or reference method for comparison is:

• "Commercially available EIA DOA tests"
• For confirmation of results, "alternate methodology preferably, GC/MS" (Gas Chromatography/Mass Spectrometry), which is considered a gold standard for drug detection.

8. The Sample Size for the Training Set:

Not applicable. The Redi-Screen is an immunochromatographic assay, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" is inherent in the design and optimization of its biochemical components (antibodies, reagents) during manufacturing and development.

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

Not applicable, as there isn't a "training set" in the context of an AI algorithm. The performance of the biochemical reagents and device design is validated against known concentrations of analytes and cross-reacting substances, using methods like GC/MS to prepare and verify those samples.

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The Redi-Test PCP is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of phencyclidine at a cut off concentration of 25ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.

The Redi-Test PCP is an immunochromatograpic based one step in vitro test.

The provided text describes the Redi-Test PCP device, its intended use, and a comparison study performed for its 510(k) submission. However, it does not explicitly state "acceptance criteria" as a predefined numerical threshold for performance. Instead, the study aims to demonstrate substantial equivalence to an existing predicate device. The performance is assessed by comparing the new device's results to the predicate device's results.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Acceptance Criteria: The document explicitly states, "The PCP Enzyme Immunoassay and the Redi-Test PCP are substantially equivalent in performance characteristics. The correlation of the two tests was >99%." This implies that the acceptance criterion for the study was to achieve a correlation of >99% and demonstrate similar performance across other key metrics (sensitivity, specificity, accuracy, precision) when compared to the predicate device. For diagnostic devices, demonstrating substantial equivalence to a legally marketed predicate device is a common regulatory pathway.

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

• Sample Size: 100 specimens (50 negative and 50 positive, covering the entire assay range).
• Data Provenance: Not explicitly stated. It is not mentioned if the data was retrospective or prospective, nor the country of origin.

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

• This information is not provided in the text. The "ground truth" for this study was the results obtained from the predicate device, the DRI Phencyclidine Enzyme Immunoassay. The study's goal was to show similarity to this established method, not to establish a new ground truth using experts.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. Since the "ground truth" was the predicate device's results, there was no expert adjudication process for the test set itself in the way it might be applied for, e.g., image interpretation based on multiple expert opinions. The comparison was directly between the Redi-Test PCP and the predicate device's readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This study is a device-to-device comparison, assessing the performance of the new device against a predicate device, not the improvement of human readers with or without AI assistance.

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

• Yes, a standalone performance study was done. The Redi-Test PCP is an in vitro diagnostic (IVD) device that provides a direct result. The comparison was of the device's output (positive/negative for phencyclidine at a specific cut-off) against the output of the predicate device. There is no "human-in-the-loop" component for interpretation described beyond the technician performing the test and reading the result.

7. The Type of Ground Truth Used

• The "ground truth" for comparison was the results obtained from the predicate device, the DRI Phencyclidine Enzyme Immunoassay. The document indicates that both assays require confirmation by an alternate methodology, preferably GC/MS, for definitive results. This suggests that while the predicate device serves as the comparative standard for this submission, the ultimate "true ground truth" for patient management would be GC/MS.

8. The Sample Size for the Training Set

• This information is not provided and is likely not relevant for this type of immunoassay device. Immunoassays typically do not have a "training set" in the machine learning sense. Their performance is inherent to their chemical and biological design. The "testing" referred to is for validation, not for training a model.

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

• This information is not applicable as there is no "training set" for an immunochromatographic device in the context of this submission.

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The Redi-Test Cocaine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of the cocaine metabolite, benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.

The Redi-Test Cocaine is an immunochromatograpic based one step in vitro test.

Here's a summary of the acceptance criteria and the study details for the Redi-Test Cocaine device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 100 specimens (50 negative, 50 positive over the entire assay range).
   • Data Provenance: Not explicitly stated, but implies collected specimens for comparison in a single study. No country of origin is mentioned, nor is it explicitly stated as retrospective or prospective. However, given the nature of a 510(k) submission for a new device, it is likely a prospective comparison study.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The "ground truth" seems to be established by the predicate device's results and confirmed by an alternate methodology (GC/MS).

3. Adjudication method for the test set:

   • Not applicable as the "ground truth" for comparison was the DRI Cocaine Enzyme Immunoassay, and confirmation was to be done by GC/MS. There is no mention of human expert adjudication in the traditional sense.

4. 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 is an in vitro diagnostic (IVD) device for substance detection, not an AI imaging or diagnostic device that involves human readers interpreting results in a comparative effectiveness study.

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

   • Yes, this was a standalone performance evaluation. The device itself performs the detection (immunochromatographic assay). The study compared the performance of this device against a predicate device.

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

   • The primary ground truth for comparison was the DRI Cocaine Enzyme Immunoassay (the predicate device). The intended use states that "preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS," indicating that GC/MS is considered the gold standard for confirmation. Therefore, the ground truth is a combination of comparison to a recognized predicate method and a gold standard confirmatory method (GC/MS).

7. The sample size for the training set:

   • Not applicable/Not specified. This is an immunoassay device, not a machine learning algorithm that requires a training set in the typical sense. The device's performance is based on its inherent chemical and immunological properties.

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

   • Not applicable. (See #7).

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The Redi-Test Methamphetamine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of d, methamphetamine at a cutoff concentration of 1000ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.

The Redi-Test Methamphelamine is an immunochromatographic based one step in vitro lest.

The provided text describes a 510(k) summary for the "Redi-Test Methamphetamine" device, comparing it to a predicate device, the "DRI Amphetamine Enzyme Immunoassay." The study is a comparative one to demonstrate substantial equivalence, rather than a standalone performance study against a predefined acceptance criterion.

Here's the information broken down:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the desired level of agreement. The study does not explicitly state pre-defined acceptance criteria in terms of sensitivity or specificity independently. Instead, it aims for substantial equivalence, which is demonstrated by a high agreement percentage with the predicate device.

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

• Sample Size: 102 specimens
  • 45 negative for methamphetamine
  • 57 positive for methamphetamine
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involves "specimens" which typically refers to real-world samples, but the collection method (retrospective or prospective) is not defined.

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

Not applicable. The ground truth for the discrepancies appears to have been established using an alternate methodology, GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard for confirming drug presence and concentration. This does not involve human experts in the sense of adjudication for interpretation, but rather a definitive analytical test.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication" for discrepant samples was performed by an objective analytical method (GC/MS), rather than human expert consensus.

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 study is for an in-vitro diagnostic (IVD) device (a chemical test kit) and does not involve human readers or AI in its diagnostic process.

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

Yes, in a way, the study evaluates the "standalone" performance of the Redi-Test Methamphetamine device by comparing its results directly to another IVD device (DRI Amphetamine Enzyme Immunoassay) and then using GC/MS for validation of discrepant results. It's a "device-only" performance assessment.

7. The Type of Ground Truth Used

• For demonstrating substantial equivalence: The predicate device, the "DRI Amphetamine Enzyme Immunoassay," served as a primary reference for comparison.
• For resolving discrepancies/validation: GC/MS (Gas Chromatography/Mass Spectrometry) was used as the definitive analytical method to determine the actual methamphetamine levels in discrepant samples.

8. The Sample Size for the Training Set

Not applicable. This is an immunochromatographic test kit, which is a chemical assay, not a machine learning or AI-based device that requires a training set. The device itself is "trained" during its manufacturing and quality control processes.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The performance characteristics are inherent to the chemistry and design of the immunochromatographic assay.

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The Redi-Test THC is designed for the qualitative determination of cannabinoids (THC) and its metabolites in human urine specimens. The presence of 11nor-Δ°-ΤΗC-9-COOH in human urine as low as 50 ng/ml can be detected. This test is for use in clinical laboratories by health care professionals and forensic professionals only.
The Redi-Test THC is a rapid immunochromatographic competitive assay used to screen human urine for the presence of cannabinoids at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed by an alternate methodology preferably GC/MS.

The Redi-Test THC is an immunochromatograpic based one step in vitro test.

Acceptance Criteria and Study Details for Redi-Test THC (K990870)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria were not explicitly defined as numerical thresholds in this 510(k) summary but were implied by the claim of "substantial equivalence" to the predicate device in terms of sensitivity, specificity, accuracy, and precision, and the 99% correlation.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 100 specimens
  • 50 positive samples
  • 50 negative samples
• Data Provenance: Not specified (e.g., country of origin). The data is retrospective, as existing specimens were used for comparison.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not described. The ground truth was established by GC/MS confirmation and comparison to a legally marketed predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. This device is an in vitro diagnostic (IVD) assay, not an imaging-based AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The study directly assessed the performance of the Redi-Test THC device by comparing its results to the predicate device and GC/MS confirmation on 100 specimens. The device's performance was evaluated independently in this context.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • External Reference Standard: Gas Chromatography/Mass Spectrometry (GC/MS) confirmation was used for objective determination of positive and negative samples below 24.7ng/mL and above 31ng/mL.
  • Comparison to Predicate Device: The DRI Cannabinoids Enzyme Immunoassay served as a comparative ground truth for evaluating correlation, sensitivity, specificity, accuracy, and precision.

8. Sample Size for the Training Set

• Sample Size: Not applicable. As an immunochromatographic assay, the Redi-Test THC does not involve a "training set" in the context of machine learning or AI algorithms. Its performance is based on its chemical and biological reactions.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.

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