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The Innovacon Flipcard™ Fecal Occult Blood Test Device is intended for rapid qualitative detection of human hemoglobin in fecal samples. Fecal occult blood tests are used as a screening tool for detecting lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyp and colorectal cancer. The Flipcard™ FOBT is recommended for use by health professionals in routine physical examinations and in monitoring for GI bleeding in patients in hospitals or at physician's offices.

The Innovacon Flipcard™ Fecal Occult Blood Test Device is a rapid test intended for the qualitative detection of low levels Fecal Occult Blood. The test uses monoclonal antibodies to selectively detect human hemoglobin in fecal samples The test uses a double antibody sandwich assay to selectively detect Fecal Occult Blood at 50 ng hHb/mL buffer or 300 ug hHB/g feces. The FOB One Step Fecal Occult Blood Test does not require the patient to follow any special dietary restrictions.

Acceptance Criteria and Study for Innovacon Flipcard™ Fecal Occult Blood Test Device

This device, the Innovacon Flipcard™ Fecal Occult Blood Test Device, is a rapid qualitative test for human hemoglobin in fecal samples, intended as a screening tool for lower gastrointestinal bleeding. The study performed aims to demonstrate substantial equivalence to a predicate device, the Hemoccult® ICT Immunological Fecal Occult Blood Test.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device, particularly regarding accuracy (positive, negative, and overall agreement). There are no explicitly stated numerical acceptance criteria for agreement percentages in the provided text. However, the reported performance demonstrates high agreement with the predicate device.

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • Part A (Sample Collection from Study Participants): 118 samples (2 positive, 116 negative based on agreement numbers).
  • Part B (Laboratory Study by Professionals): 150 samples (48 positive, 102 negative based on agreement numbers).
  • The document also states "A clinical evaluation was conducted using a total of 120 clinical specimens" but the sum of samples for Part A and Part B (118+150 = 268) is significantly higher. It's possible that the "120 clinical specimens" refers to a subset or a different overarching study, and the detailed breakdown for Part A and Part B are distinct analyses within larger datasets.
• Data Provenance: The document does not explicitly state the country of origin for the data. The study involved "clinical specimens," suggesting a prospective collection for the purpose of the evaluation, but it doesn't explicitly state "prospective" or "retrospective." Given the mention of "clinical evaluation," it implies real-world samples were used.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications. The "ground truth" for this study is the result obtained from the predicate device, Hemoccult® ICT.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The comparison is made directly between the new device and the predicate device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the new device against a predicate device, not in the context of human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone comparison was done. The study's "Accuracy" section describes the Innovacon Flipcard™ Fecal Occult Blood Test Device's performance directly against the predicate device, Hemoccult® ICT, without the explicit involvement of human readers interpreting results from both. The results for "Part A: Sample Collection from Study Participants" and "Part B: Laboratory Study by Professionals" represent the device's performance in detecting fecal occult blood.

7. Type of Ground Truth Used

The "ground truth" used in this study is the result obtained from the predicate device, Hemoccult® ICT Immunological Fecal Occult Blood Test. The study design is a comparison of the new device's performance against an already legally marketed and established device, rather than against an absolute gold standard like pathology or long-term outcomes data.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This device is a rapid diagnostic kit, rather than a machine learning algorithm that typically requires a distinct training phase. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set, the method for establishing its ground truth is not provided and is not applicable to this type of device submission.

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The Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated Cups (Innovacon 014 Cup or E-Z Action Multi-Drug Test Cup and Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methylenedioxymethamphetamine, Methamphetamine, Phencyclidine, Morphine, Opiates, Methadone, Amphetamine, Benzodiazepine, Oxycodone, Propoxyphene, Tricyclic Antidepressants, Buprenorphine and Barbiturate in human urine at the cutoff concentrations of:

1,000 ng/mL or 300 ng/mL for Amphetamine, 300 ng/mL for Barbiturate, 300 ng/mL for Benzodiazepines, 300 ng/mL or 150 ng/mL for Cocaine, 50 ng/mL for Marijuana, 300 ng/mL for Methadone, 500 ng/mL or 1,000 ng/mL for Methamphetamine, 500 ng/mL for Methylenedioxymethamphetamine, 300 ng/mL for Morphine, 2,000 ng/mL for Opiates, 100 ng/mL for Oxycodone, 25 ng/mL for Phencyclidine, 300 ng/mL for Propoxyphene, 10 ng/mL for Buprenorphine, and 1,000 ng/mL for Tricyclic Antidepressants.

Configurations of the Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated Cups (Innovacon 014 Cup or E-Z Action Multi-Drug Test Cup and Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup) can consist of any combination of the above listed drug analytes. They are intended for healthcare professionals including professionals at point-of-care sites.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated Cups (Innovacon 014 Cup or E-Z Action Multi-Drug Test Cup and Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup) are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methylenedioxymethamphetamine, Methamphetamine, Phencyclidine, Morphine, Opiates, Methadone, Amphetamine, Benzodiazepine, Oxycodone, Propoxyphene, Tricyclic Antidepressants, Buprenorphine and Barbiturate in human urine at the cutoff concentrations of:

1,000 ng/mL or 300 ng/mL for Amphetamine, 300 ng/mL for Barbiturate, 300 ng/mL for Benzodiazepines, 300 ng/mL or 150 ng/mL for Cocaine, 50 ng/mL for Marijuana, 300 ng/mL for Methadone, 500 ng/mL or 1,000 ng/mL for Methamphetamine, 500 ng/mL for Methylenedioxymethamphetamine, 300 ng/mL for Morphine, 2,000 ng/mL for Opiates, 100 ng/mL for Oxycodone, 25 ng/mL for Phencyclidine, 300 ng/mL for Propoxyphene, 10 ng/mL for Buprenorphine, and 1,000 ng/mL for Tricyclic Antidepressants.

These tests can be performed without the use of an instrument.

A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing of Marijuana, Cocaine, Methylenedioxymethamphetamine, Amphetamine, Opiates, Methadone, Methamphetamine, Phencyclidine, Benzodiazepine, Propoxyphene, Tricyclic Antidepressants, Buprenorphine and Barbiturate at the concentrations below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a color line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

The provided text describes a 510(k) submission for a multi-drug screening device. While it details the device's intended use and classification, it does not include specific acceptance criteria, comprehensive performance study results (beyond stating it's "similar to other FDA-cleared devices"), or information about training data, ground truth establishment, or expert involvement in evaluation.

Therefore, many of the requested points cannot be extracted from the given input.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Not provided in the document. The document states the device is "similar to other FDA-cleared devices for the qualitative and simultaneous detection..." implying that its performance aligns with those predicate devices, but no explicit acceptance criteria or detailed performance metrics are listed for the Innovacon Spectrum II Test Card itself.

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

Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided in the document.

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

Not provided in the document.

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 is a rapid immunoassay for qualitative detection of substances in urine, not an AI-assisted diagnostic imaging device that uses human readers.

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

This device is a "standalone" test in the sense that it's a lateral flow immunoassay performed without an instrument, directly producing a visual result. However, it's not an algorithm, so the phrasing "algorithm only" doesn't quite fit. The document specifies, "These tests can be performed without the use of an instrument." The results are interpreted visually by a healthcare professional at point-of-care.

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

The document states, "This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) are the preferred confirmatory methods." This indicates that GC/MS would be the primary method for establishing ground truth/confirmation.

8. The sample size for the training set

Not provided in the document.

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

Not provided in the document, but it's reasonable to infer that if a training set were used (which is typical for device development, though not explicitly mentioned here), the ground truth for it would also rely on confirmatory methods like GC/MS, consistent with item #7.

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Innovacon™ hCG Ultra Test Device is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. It is for healthcare professionals only.

The test utilizes a combination of antibodies including mouse monoclonal antihCG antibodies and goat polyclonal anti-hCG antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding urine or serum specimens to the specimen well of the test device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.

Positive specimens react with the specific colored antibody conjugates and form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

The Innovacon™ hCG Ultra Test Device is a rapid test that qualitatively detects hCG at the sensitivity of 10 mIU/mL in serum and 20 mIU/mL in urine. The cutoff concentration of this test has been standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589). At the level of claimed sensitivity, the hCG Ultra Test Device shows no cross-reactivity interference from the structurally related glycoprotein hormones FSH, LH and TSH at extra high physiological levels.

The provided text describes the Innovacon™ hCG Ultra Test Device, a pregnancy test kit for professional use, and its 510(k) clearance (K062361). The clearance document confirms the device's substantial equivalence to a legally marketed predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" as a formal table with quantitative targets. Instead, it describes performance characteristics and claims substantial equivalence to a predicate device. The primary "acceptance criteria" appear to be:

• Qualitative detection of hCG in serum or urine.
• Sensitivity: 10 mIU/mL in serum and 20 mIU/mL in urine.
• No cross-reactivity with FSH, LH, and TSH at extra high physiological levels.
• Robustness and accurate results under adverse conditions (referring to various laboratory studies).
• Ease of use, clear labeling, and interpretable results.

Here's a table summarizing the performance claims:

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

The text refers to a "clinical study" and "POL study" (presumably referring to Point-of-Care/Limited laboratory settings), but does not specify the sample size for these studies.

• Data Provenance: The clinical study was "conducted in three sites in the U.S." This indicates the data is from the United States and appears to be prospective, as it was conducted specifically to evaluate the new device.

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

The document does not specify the number of experts used or how ground truth was established for the clinical study. It mentions the study was conducted by "healthcare professionals with varying educational backgrounds and laboratory experience." This suggests general healthcare professionals were involved but doesn't detail their qualifications for establishing a definitive ground truth for hCG levels.

4. Adjudication Method for the Test Set

The text does not describe any adjudication method (e.g., 2+1, 3+1, none) for reconciling discrepancies or establishing a definitive ground truth in the clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

The document describes a "performance equivalency" study comparing the Innovacon device to the Fisher Sure-Vue Serum/Urine hCG-STAT test. It states this was done "by professionals," implying human readers were involved. However, it does not explicitly state that it was an MRMC study designed to measure the effect size of human readers improving with or without AI assistance. This is a rapid immunoassay, not an AI-powered diagnostic imaging device, so conventional MRMC studies measuring AI assistance are not applicable. The comparison here is between two different test kits as interpreted by human users.

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

This question is not applicable to this device. The Innovacon hCG Ultra Test Device is a rapid chromatographic immunoassay, which is a physical test kit requiring human interpretation of colored lines, not an algorithm or AI system. Its performance is inherently linked to human-in-the-loop steps (applying samples, reading results).

7. The Type of Ground Truth Used

The type of ground truth is not explicitly stated. Given that it's a pregnancy test, the ground truth would typically be established by:

• Laboratory reference methods: More sensitive and quantitative hCG assays (e.g., quantitative serum hCG).
• Clinical outcomes: Confirmation of pregnancy via ultrasound or other clinical signs.
• Predicate device results: In the context of a substantial equivalency claim, the results from the predicate device (Fisher Sure-Vue Serum/Urine hCG-STAT) would serve as a comparative ground truth.

The document states the device's cutoff concentration was "standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589)," indicating a scientific basis for the hCG levels.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is consistent with a traditional immunoassay device, which does not typically involve machine learning requiring training data. The "training" in this context would likely refer to the development and optimization of the assay components and parameters.

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

As there is no explicit mention of a training set in the AI/ML sense, this question is not applicable. The development of the assay's sensitivity and specificity would have been based on established medical and biological principles for detecting hCG, potentially using characterized hCG samples standardized to international references.

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