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510(k) Data Aggregation
(262 days)
The Distinct® Early Detection Pregnancy Test is an aid for the early detection of pregnancy intended for home use. The device is a chromatographic immunoassay that performs qualitative detection of human chorionic gonadotropin (hCG) in urine. This test can help determine pregnancy as early as 6 days before the day of the missed period (5 days before the day of the expected period).
The Distinct® Early Detection Pregnancy Test is a rapid chromatographic immunoassay for in vitro qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. It is for self-testing. The test strip and absorbent tip are assembled in a plastic housing. The test strip contains monoclonal anti-hCG antibodies and goat anti-mouse polyclonal antibodies. The test result is shown in the result window and read visually after 3 minutes of urine application.
A blue sign of plus (+) at the test window indicates that hCG has been detected (pregnant). Absence of the plus (+) and only a blue line (-) in the Test Window suggests no hCG has been detected. To serve as a procedural control, a blue line will always appear in the Control Window indicating that proper volume of specimen has been added and membrane wicking has occurred.
The provided information describes the validation study for the "Distinct® Early Detection Pregnancy Test." Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with specific thresholds. However, based on the studies performed, the implied performance criteria for this qualitative immunoassay are high agreement with a predicate device and high sensitivity (low detection limit for hCG).
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (Detection Limit) | Detect 10 mIU/mL hCG with 100% positivity | 100% of samples were positive at 10 mIU/mL hCG and higher. |
| Accuracy (Lay User vs. Professional) | >99% agreement with predicate device (professional use) | Urine Stream Method: 100% agreement (51 Pos, 51 Neg by both, 0 disagreement). |
| Urine Dipping Method: 100% agreement (52 Pos, 51 Neg by both, 0 disagreement). Overall accuracy >99%. | ||
| Cross-Reactivity | No cross-reactivity with FSH, TSH, LH up to 1000 mIU/mL/µIU/mL | No cross-reactivity observed with 1000 mIU/mL FSH, 1000 µIU/mL TSH, and 1000 mIU/mL LH. |
| Interference | No interference from common endogenous/exogenous substances | None of the tested endogenous or exogenous substances interfered with expected results. |
| pH Effects | No interference from urine pH 4-9 | Urine pH range of 4 to 9 did not interfere with performance. |
| Specific Gravity Effects | No interference from urine specific gravity 1.003-1.035 | Urinary specific gravity over the range of 1.003 - 1.035 did not influence results. |
| High Dose Hook Effect | No false negatives at high hCG concentrations up to 1,000,000 mIU/mL | No hook effect observed at hCG concentrations up to 1,000,000 mIU/mL. |
| hCG ß-Core Fragment Effects | No false negatives due to high ß-Core Fragment concentrations | No hook effect observed at ß-Core Fragment concentrations up to 1,000,000 pmol/L. |
| Early Pregnancy Detection | Detect pregnancy at various days before expected period (comparable to predicate) | EMP: 100% positive; EMP-1 day: 100% positive; EMP-2 days: 100% positive; EMP-3 days: 96.9% positive; EMP-4 days: 93.8% positive; EMP-5 days: 75.4% positive; EMP-6 days: 49.2% positive; EMP-7 days: 20.3% positive; EMP-8 days: 10.0% positive. |
| Negative Predictive Value (Non-Pregnant Women) | No false positives in non-pregnant women across age groups | No positive results observed for any of the 300 non-pregnant subjects across three age groups. |
| Ease of Use (Laypersons) | Can be performed correctly and is easy to use by laypersons | Study results indicate it can be performed correctly by laypersons and is easy to use. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Precision/Reproducibility Study:
- Sample Size: 30 negative urine specimens spiked with hCG at various concentrations (3, 5, 6, 7.5, 8, 8.5, 10, 12, 15, and 25 mIU/mL).
- Data Provenance: Not explicitly stated, but implies laboratory-prepared samples. Retrospective (spiked samples).
- User Performance Study:
- Sample Size: 205 laypersons.
- Data Provenance: Not explicitly stated, but implies U.S. or similar country where FDA approval is sought. Prospective (lay users testing their own urine).
- Device Performance in Different Age Groups:
- Sample Size: 300 subjects (100 for each age group: 18-40, 41-45, and 55+).
- Data Provenance: Not explicitly stated. Prospective (subjects providing samples).
- Detection of hCG in Early Pregnancy Clinical Samples:
- Sample Size: 65 non-pregnant women expecting to become pregnant.
- Data Provenance: Not explicitly stated. Prospective (daily urine collection from women).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Precision/Reproducibility Study: The ground truth (hCG concentration) was established by spiking negative urine specimens with known concentrations of WHO 5th International hCG standard. No human experts were explicitly mentioned for interpreting the spiked samples' "true" status, as it's a controlled analytical test.
- User Performance Study: The ground truth for comparative results was established by professional testing with the predicate device using the same samples tested by laypersons. The qualifications of these professionals are not specified beyond "professional" use.
- Device Performance in Different Age Groups: The ground truth for "non-pregnant" status was assumed based on the study design for non-pregnant women. No experts were mentioned for establishing ground truth; it was based on the absence of hCG.
- Detection of hCG in Early Pregnancy Clinical Samples: The ground truth of pregnancy status was inferred from positive hCG results over time relative to the expected menstrual period. It's not explicitly stated that an "expert" individually established the ground truth for each sample. The study assesses the device's ability to detect hCG in early pregnancy, with the "truth" being the presence or absence of a detectable hCG level over time.
4. Adjudication Method for the Test Set:
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth from multiple human readers for any of the studies.
- In the User Performance Study, the comparison was between the layperson's interpretation of the candidate device and a professional's interpretation of the predicate device (or presumably, professional interpretation of the candidate device in parallel, though the wording specifies "compared to results from the same sample performed with the predicate device"). This implies a direct comparison rather than an adjudication process involving multiple readers for 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:
- No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This device is a rapid chromatographic immunoassay (a traditional dipstick-style pregnancy test) and does not involve AI or digital image analysis by human readers. The "reader" is directly the lay user who visually interprets the test line.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. The device is a visual qualitative test designed for direct human interpretation. There is no algorithm involved in interpreting the results.
7. The Type of Ground Truth Used:
- Analytical Performance Studies (Precision, Cross-Reactivity, Interference, Hook Effect, etc.): The ground truth was primarily based on known concentrations of spiked hCG and other substances (e.g., WHO 5th International Standard for hCG, known concentrations of interfering substances).
- User Performance Study: The ground truth for comparison was established by professional use of a predicate device on the same samples.
- Device Performance in Different Age Groups: Ground truth was based on the confirmed non-pregnant status of the subjects.
- Detection of hCG in Early Pregnancy Clinical Samples: Ground truth for pregnancy detection over time was based on the presence/absence of hCG in urine samples collected prospectively from women trying to conceive, with "positive" samples validated by the test itself and monitored over time relative to the expected period.
8. The Sample Size for the Training Set:
- This device is a traditional immunoassay, not an AI/ML device. Therefore, the concept of a "training set" for an algorithm is not applicable. The device itself (the physical test strip) is manufactured based on established principles of immunoassay development.
9. How the Ground Truth for the Training Set Was Established:
- As stated above, there is no training set as this is not an AI/ML device. The "ground truth" in the development of such assays typically comes from established scientific principles, calibrated reference materials (like WHO standards), and extensive R&D to ensure the antibodies and reagents perform as expected for hCG detection.
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(218 days)
The Mission® Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip. The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
HDL (High Density Lipoprotein Cholesterol) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Trighcerides measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.
Use this product at the frequency your doctor recommends for testing Total Cholesterol, and Triglycerides.
An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL.
The Mission® Cholesterol Pro Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip and lithium heparin venous whole blood. The Mission Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter, Mission Cholesterol Pro Test Cartridges, Mission Cholesterol Optical Verifier, and Mission Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
HDL (High Density Lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Triglycerides measurements are used in the diagnosis and treatments with diabetes mellitus. nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.
An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL.
Over the Counter (home use): The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Meter, Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution and is intended to be used by a single person and should not be shared.
The Mission Cholesterol Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary whole blood from the fingertip. The Mission Cholesterol Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis.
Professional: The Mission Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter. Mission Cholesterol Pro Test Cartridges. Mission Cholesterol Pro Optical Verifier and Mission Cholesterol Pro Control Solution and is intended for professional use in healthcare settings for multiple patient uses.
The Mission Cholesterol Pro Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary and venous human whole blood. The Mission Cholesterol Pro Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis.
Test Cartridge:
The Mission Cholesterol (Home use) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary whole blood from the fingertip. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter.
The Mission Cholesterol Pro (Professional) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary and venous human whole blood. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter.
Control Solution:
Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Control Solutions are used to estimate precision of meter readings for determination of total cholesterol (CHOL), high density lipoprotein cholesterol (HDL) and triglycerides (TRIG).
Optical verifier:
Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Optical Verifiers are used to verify that the meter functions properly by checking that the meter can detect a pre-calibrated value.
Here's a summary of the acceptance criteria and study findings for the Mission Cholesterol Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" values in a table. However, the linearity, precision, and bias data are direct measures of performance against presumed internal or regulatory benchmarks for acceptable accuracy and precision in cholesterol measurement devices. We will infer the reported device performance from the study results presented.
| Performance Metric | Acceptance Criteria (Implied/Industry Norms) | Reported Device Performance - Total Cholesterol | Reported Device Performance - HDL Cholesterol | Reported Device Performance - Triglycerides |
|---|---|---|---|---|
| Precision (Repeatability %CV) | Generally <5% for diagnostic devices (Level 1, Level 2) | Level 1: 1.5%, Level 2: 1.6% | Level 1: 2.0%, Level 2: 1.6% | Level 1: 1.3%, Level 2: 1.6% |
| Precision (Total Precision %CV) | Generally <10% for diagnostic devices (Level 1, Level 2) | Level 1: 2.0%, Level 2: 1.8% | Level 1: 2.7%, Level 2: 2.3% | Level 1: 2.0%, Level 2: 1.9% |
| Linearity (Measurement Range) | Device should be linear within its claimed measurement range | 100-400 mg/dL (linear detection range) | 15-100 mg/dL (linear detection range) | 45-650 mg/dL (linear detection range) |
| Correlation ($R^2$) - Layperson, Finger Capillary | Typically >0.90 for good correlation | 0.9846 | 0.9768 | 0.9934 |
| Correlation ($R^2$) - Professional, Finger Capillary | Typically >0.90 for good correlation | 0.9883 | 0.9778 | 0.9948 |
| Correlation ($R^2$) - Professional, Heparin Venous | Typically >0.90 for good correlation | 0.9863 | 0.9790 | 0.9936 |
| % Bias at Medical Decision Points (Finger Blood) | Generally within ±5-10% for clinical acceptability | (-0.1% at 200mg/dL, -0.1% at 240mg/dL) | (-0.3% at 40mg/dL, -0.1% at 60mg/dL) | (0.3% at 150mg/dL, 0.0% at 200mg/dL, -0.2% at 500mg/dL) |
| % Bias at Medical Decision Points (Venous Blood) | Generally within ±5-10% for clinical acceptability | (-0.7% at 200mg/dL, -0.8% at 240mg/dL) | (1.9% at 40mg/dL, 1.0% at 60mg/dL) | (-1.8% at 150mg/dL, -1.5% at 200mg/dL, -1.2% at 500mg/dL) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 369 patients were recruited for the clinical study.
- Data Provenance: The study was conducted at three point-of-care (POC) sites located in different geographical locations. It is a prospective clinical study as patients were recruited and tested specifically for this study. The country of origin is not explicitly stated, but given the FDA submission, it can be inferred to be compliant with US regulatory standards, likely involving data collected within the US or under equivalent standards.
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. However, it mentions:
- "For professional use, patient blood was collected from fingertip and venous blood draws. Capillary blood samples from fingertip were tested at clinical sites by professionals. Venous blood samples were tested at a laboratory using an FDA cleared method."
- "The plasma concentration was confirmed by the reference method."
This implies that trained "professionals" (likely medical technicians or laboratory personnel) performed the official comparative testing, and an FDA-cleared reference method was used to establish the ground truth. No specific number or qualification (e.g., "radiologist with 10 years of experience") for these "professionals" is given beyond their professional role in clinical sites or laboratories.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1). The ground truth was established by comparing the device's results to an "FDA cleared method" and a "reference method" in laboratory settings. This suggests direct quantitative comparison rather than a consensus-based adjudication process typical for qualitative or image-based diagnostics.
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 explicitly mentioned or performed in the context of improving human reader performance with AI assistance. This study focuses on the device's standalone analytical performance compared to a reference method, and also includes layperson use, not assisted reading by human experts.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was done for the device. The entire clinical study, comparing the Mission Cholesterol Monitoring System's measurements against a reference method, evaluates the algorithm's performance. Both professional operators and laypersons used the device independently to obtain results, which were then compared to the established ground truth.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established by comparing the device's results to an FDA cleared method and a reference method (for plasma concentration).
8. The Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. The studies described are for the validation of an already developed device.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, there's no information on how its ground truth would have been established. The provided document focuses on the validation of the device through performance and clinical studies.
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