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MissLan® Early Detection Pregnancy Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

MissLan® Early Detection Pregnancy Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

This device is intended for home-use only.

MissLan® Early Detection Pregnancy Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

This device is intended for home-use only.

Device Description

MissLan® Early Detection Pregnancy Test will be sold in Strip. Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode.

MissLan® Early Detection Pregnancy Test Strip. MissLan® Early Detection Pregnancy Test Cassette and MissLan® Early Detection Pregnancy Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper and urine collection cup.

The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.

AI/ML Overview

The provided FDA 510(k) summary describes the acceptance criteria and study results for the MissLan® Early Detection Pregnancy Test Strip, Cassette, and Midstream devices.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and reported device performance

The document does not explicitly state "acceptance criteria" as a separate section with numerical targets for each performance metric. However, the performance characteristics studies demonstrate that the device meets the necessary performance for its intended use, implying that the observed results constitute the criteria it should achieve. The predicate device's performance often forms the implicit benchmark for substantial equivalence.

Based on the provided data, the implicit acceptance criteria and reported performance are as follows:

Acceptance Criterion (Implicit)	Reported Device Performance
Analytical Sensitivity (Limit of Detection): Ability to detect hCG at 10 mIU/mL.	100% detection at 10 mIU/mL for all formats (Strip, Cassette, Midstream - both dip and in-stream methods) across all operators and lots.
Reproducibility: Consistent results across operators, lots, and days.	Demonstrated high reproducibility across varying hCG concentrations, operators, and lots. For example, 100% positive agreement at 10, 15, and 25 mIU/mL, and 100% negative agreement at 0 and 3 mIU/mL.
Hook Effect: No false negative results at very high hCG concentrations.	No hook effect observed up to 500,000 mIU/mL for all formats.
Interfering Substances: No interference from common substances in urine.	No interference observed from 23 listed endogenous and exogenous substances (e.g., Albumin, Bilirubin, Glucose, Hemoglobin, common drugs) at specified concentrations.
Cross-reactivity: No false positives from structurally similar hormones (hLH, hFSH, hTSH).	No cross-reactivity observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, and 1000 µIU/mL hTSH.
hCG ß-core fragment effect: Performance not affected by hCG ß-core fragments.	Performance not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
Urine pH effect: Performance robust across physiological urine pH range.	Urine pH values between 4 and 9 do not affect performance.
Urine Density effect: Performance robust across physiological urine density range.	Urine with relative density range of 1.000 to 1.035 does not affect performance.
Method Comparison with Predicate Device: High concordance with the legally marketed predicate.	100% conformity between the candidate device (all formats) and the predicate device across 400 clinical urine samples (100 for each format/method).
Lay Person Readability/Accuracy: High agreement with professional results when used by laypersons.	First Study: 100% positive and 100% negative conformity with professional results for all formats (total 400 laypersons, 100 for each format/method, using clinical samples).
Second Study: Percent agreement with professional results ranges from 95% to 100% for various hCG spike concentrations (300 laypersons, 100 for each format, testing spiked urine samples). Specifically, 100% agreement at 0 and 10 mIU/mL, and 95-97% agreement at 3.5 and 6.5 mIU/mL.
Early Pregnancy Detection Rate: Ability to detect pregnancy early, especially before a missed period.	Detection Rate at EMP-5: 76.92% (5 days before expected period).
Detection Rate at EMP-4: 96.92%.
Detection Rate at EMP-3 and later: 100% (3 days before expected period and thereafter).
False-Positive Rate (Specificity): No false positives in non-pregnant individuals.	0% false positive results among 900 non-pregnant female urine samples (300 pre-menopausal, 300 peri-menopausal, 300 post-menopausal, across various formats and lots).

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

Analytical Performance (Precision/Reproducibility/Sensitivity):

Sample Size: 3 lots x 3 operators x 10 replicates x 9 hCG concentrations = 810 tests per device format. Since there are 4 effective formats (strip, cassette, midstream in-stream, midstream dip), this would be 810 x 4 = 3240 individual test results for this section.
Data Provenance: Retrospective. Negative female urine was spiked with hCG standard.

Method Comparison Study:

Sample Size: 400 women. Samples were divided: 100 for strip, 100 for cassette, 100 for midstream (dip), 100 for midstream (in-stream).
Data Provenance: Prospective, collected from women aged 18 to 51 at three clinical sites. Approximately half were early pregnant. Samples were collected randomly throughout the day. Country of origin not specified, but typically US or manufacturer's country due to regulatory context.

Lay Person Study (First Study - Clinical Samples):

Sample Size: 400 females (100 for each device format/method).
Data Provenance: Prospective, from "diverse educational and occupational backgrounds and ages ranging from 18 to 51 years old" at three sites. Country not specified.

Lay Person Study (Second Study - Spiked Samples):

Sample Size: 300 laypersons (100 for each device format). Each tested 4 blind-labeled spiked samples, so 300 * 4 = 1200 tests.
Data Provenance: Retrospective, using negative urine samples spiked with hCG. Country not specified.

Early Pregnancy Detection Study:

Sample Size: 65 pregnant women, contributing 650 early pregnancy urine samples (from day -8 to day +1 relative to the day of expected menstrual period).
Data Provenance: Prospective, collected from pregnant women. Country not specified.

Specificity Study (False-Positive Results Rate):

Sample Size: 900 urine samples from non-pregnant females (300 pre-menopausal, 300 peri-menopausal, 300 post-menopausal). These were divided further by device format (e.g., for each age group, 100 for strip, 100 for cassette, 50 for midstream dip, 50 for midstream in-stream).
Data Provenance: Clinical, collected from non-pregnant females at three sites. Country not specified.

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

Analytical Performance (Precision/Reproducibility/Sensitivity): 3 operators performed the tests for the device, but the "ground truth" for hCG concentration was based on spiking with a standard traceable to the 5th WHO.
Method Comparison Study: "Three professionals at each site" tested the candidate device, and "one professional at each site" tested the predicate device. Their specific qualifications are not detailed beyond "professional." It's implied they are trained laboratory personnel.
Lay Person Study (First Study - Clinical Samples): "Professional" testing was used as ground truth for comparison with layperson results. The number of professionals is not specified, nor their detailed qualifications, but it implies a single assessment for ground truth by trained personnel.
Lay Person Study (Second Study - Spiked Samples): "Professional" testing was used as ground truth, but the ultimate ground truth was the known hCG concentration of the spiked samples.
Early Pregnancy Detection Study: The ground truth for pregnancy status was established by B-ultrasound and HCG levels for the 65 pregnant women/650 samples. This refers to established clinical diagnostic methods, implying expert medical interpretation of ultrasound and quantitative lab HCG results.
Specificity Study: The samples were collected from "non-pregnant females," implying a clinical determination of non-pregnancy as ground truth.

4. Adjudication method for the test set

The document does not explicitly describe an adjudication method (such as 2+1 or 3+1 consensus) for establishing ground truth from multiple experts.
In studies involving comparisons (e.g., method comparison, layperson study), results from "professionals" or "known spiked concentrations" served as the reference standard (ground truth). For the early pregnancy detection study, B-ultrasound and HCG levels were the ground truth, which are typically conclusive diagnostic methods.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted, nor is this device an AI-assisted device. This device is a rapid in-vitro diagnostic (IVD) test for qualitative detection of HCG. The "readers" are either laypersons or professionals interpreting a visual line on a test strip.

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

This question is not applicable as the device is a manual, visually interpreted rapid diagnostic test, not an algorithm or software. It is inherently human-in-the-loop (for reading the result).
However, the analytical performance studies (e.g., precision, hook effect, interfering substances) could be considered "standalone" in the sense that they assess the device's chemical and physical characteristics independent of human interpretation variability, but still involve human technicians performing the tests.

7. The type of ground truth used

Analytical Performance Studies (Precision/Reproducibility, Hook Effect, Interfering Substances, Cross-Reactivity, HCG ß-core fragment, pH, density): Ground truth was based on known spiked concentrations of hCG (traceable to WHO standard) or interfering substances into negative urine.
Method Comparison Study: Ground truth was established by comparison to a legally marketed predicate device (Wondfo One Step HCG Urine Pregnancy Test) and/or potentially by clinical reference methods by professionals.
Lay Person Study (First Study): Ground truth was established by professional testing results of the same clinical urine samples.
Lay Person Study (Second Study): Ground truth was based on known spiked concentrations of hCG and confirmed by professional testing.
Early Pregnancy Detection Study: Ground truth was established by clinical B-ultrasound and HCG levels to confirm pregnancy status and gestational age.
Specificity Study: Ground truth was the clinical diagnosis of non-pregnant females.

8. The sample size for the training set

The document does not specify a separate "training set" for the device. This is typical for traditional rapid diagnostic tests, which are validated against established performance metrics rather than trained via machine learning. The studies described are validation and verification studies.

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

As there's no specified "training set" in the context of machine learning, this question is not directly applicable. The ground truth for validation/verification studies was established as described in point 7.

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