Search Results

CareStart™ Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, CK-MB and myoglobin in human blood, serum qualitative detection of cardiac troponin I, CK-MB and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

CareStart™ Cardiac 2-in-1 Troponin I/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, and myoglobin in human blood, serum or plasma. detooking of cardiae troponin I, and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

CareStart™ Cardiac CKMB Test is intended for the qualitative detection of CK-MB in human blood, serum or plasma. Measurement of CK-MB aids in rapid diagnosis of numan blood, corant of on. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

CareStart™ Cardiac Troponin I Test is intended for the qualitative detection of cardiac oarcotar troponiir in haman broomyocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

Not Found

This document is a 510(k) premarket notification for the CareStart Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test, CareStart Cardiac 2-in-1 Troponin I/Myoglobin Test, CareStart Cardiac Troponin I, and CareStart Cardiac CK-MB devices.

Per the provided document, the FDA has determined that the device is substantially equivalent to legally marketed predicate devices. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with predefined acceptance criteria and performance metrics.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria and a study proving the device meets them in the format typically seen for novel devices requiring extensive clinical validation. The approval is based on the device's similarity to existing devices already on the market.

However, I can extract the information that is present concerning the intended use and performance in a general sense:

1. A table of acceptance criteria and the reported device performance:
   The document does not provide a table of acceptance criteria nor reported device performance metrics (e.g., sensitivity, specificity, accuracy, PPV, NPV) from a dedicated study. The FDA's substantial equivalence determination implies that the device performs comparably to the predicate devices, which would have established performance characteristics.

2. Sample size used for the test set and the data provenance:
   This information is not provided in the document. The filing is a 510(k) and does not detail a specific performance study with a test set.

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.

4. Adjudication method for the test set:
   This information is 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:
   This is not applicable. These are in-vitro diagnostic tests for qualitative detection of biomarkers, not AI-assisted imaging or diagnostic devices where human reader performance would be a factor in an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This is not applicable. These are diagnostic test kits, not algorithms. Their performance is inherent to the kit itself.

7. The type of ground truth used:
   This information is not explicitly stated in the document. For in-vitro diagnostic tests like these, ground truth for performance studies would typically be established by laboratory reference methods or clinical diagnosis supported by multiple lines of evidence for the target condition (acute myocardial infarction).

8. The sample size for the training set:
   This information is not provided in the document. (Not typically relevant for 510(k) submissions of IVD kits that are based on chemical reactions rather than machine learning algorithms.)

9. How the ground truth for the training set was established:
   This information is not provided in the document. (Not typically relevant for 510(k) submissions of IVD kits.)

Summary of what can be inferred from the document:

• Device Intended Use: The devices are intended for the qualitative detection of cardiac biomarkers (Troponin I, CK-MB, Myoglobin) in human blood, serum, or plasma to aid in the rapid diagnosis of acute myocardial infarction.
• Regulatory Class: Class II
• Prescription Use: All listed devices are for prescription use.
• Point-of-Care (POC) Setting: The performance characteristics have not been evaluated in a point-of-care (POC) setting, meaning their use is intended for laboratory or clinical settings where trained personnel can perform the test.
• Basis for Approval: Substantial equivalence to legally marketed predicate devices, meaning the FDA believes these devices are as safe and effective as existing devices for their stated indications. This does not involve independent clinical trials detailed within this specific 510(k) submission.

Ask a specific question about this device

CareStart™ Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for over-the counter sale to laypersons.

Not Found

The provided text is a 510(k) clearance letter for the CareStart™ Pregnancy Test and CareStart PLUS™ Pregnancy Test. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive summary of safety and effectiveness (SSE).

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I answer many of the specific questions about the study design, sample sizes, ground truth establishment, or expert qualifications.

The only information directly related to performance from this document is:

• Intended Use: Qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
• Target User: Laypersons (over-the-counter sale).

To fully answer your request, a more detailed document, such as a 510(k) summary (which often contains safety and effectiveness data), would be required.

Based on the provided text, here's what can and cannot be answered:

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

• Cannot be provided as this information is not in the clearance letter. Acceptance criteria and specific performance metrics (like sensitivity and specificity at various hCG levels) are typically found in the clinical study report or 510(k) summary, not the clearance letter itself.

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

• Cannot be provided as this information is not in the clearance letter.

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):

• Cannot be provided as this information is not in the clearance letter. (For a pregnancy test, ground truth would likely be established by a reference method measuring hCG levels, not typically by expert interpretation of the test result itself in a clinical study context for regulatory submission.)

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

• Cannot be provided as this information is not in the clearance letter.

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 device is a rapid diagnostic test (pregnancy test), not an AI-assisted diagnostic imaging device or an AI application that would be used by human readers in an MRMC study.

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

• Not applicable. This device is a rapid diagnostic test that provides a visual result for the user. It is inherently "standalone" in that it performs its function without a separate algorithm needing to be assessed for standalone performance. The "human-in-the-loop" here is the layperson interpreting the visual result.

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

• Cannot be definitively stated from this document. For a pregnancy test, the ground truth for establishing performance is almost always a quantitative laboratory method (e.g., ELISA, RIA, or other highly sensitive and specific quantitative hCG assays) that measures the actual concentration of hCG in urine or serum, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Cannot be provided as this information is not in the clearance letter.

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

• Cannot be provided as this information is not in the clearance letter. (As mentioned above, for pregnancy tests, it's typically based on quantitative laboratory hCG measurements.)

Ask a specific question about this device

CareStart™ hCG Combo One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.

Not Found

The provided text is related to a 510(k) premarket notification for a pregnancy test device, not an AI device. As such, the information typically requested for AI device studies (like acceptance criteria tables, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment methods) is not available in the document.

Therefore, I cannot provide the requested information from the text you provided.

Ask a specific question about this device

CareStanTM hCG One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by health care professionals.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a pregnancy test, which states that the device is substantially equivalent to a legally marketed predicate device.

The letter mentions:

• Device Name: CareStart™ hCG One-Step Pregnancy Test and CareStart Plus - hCG One-Step Pregnancy Test
• Regulation Number: 21 CFR 862.1155 (Human chorionic gonadotropin (HCG) test system)
• Intended Use: Qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy, intended for use by health care professionals.

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method.
5. Information about any MRMC comparative effectiveness study or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This kind of detailed study information is typically found in the "Summary of Safety and Effectiveness" or a similar document that would have been submitted as part of the 510(k) application, but it is not present in the provided FDA clearance letter itself.

Ask a specific question about this device