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Shinetell Plus™ Digital Early Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Device Description

Shinetell Plus™ Digital Early Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format.

Shinetell Plus™ Digital Early Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Shinetell Plus™ Digital Early Pregnancy Test, based on the provided 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter does not explicitly state "acceptance criteria" as a separate, quantitative table. However, we can infer the acceptance criteria from the performance studies presented, particularly the sensitivity and agreement rates. The primary criterion is demonstrating a sensitivity of 10 mIU/mL and high agreement with professional results and the predicate device.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Analytical Sensitivity (LOD)	10 mIU/mL (based on predicate and stated sensitivity)	Midstream & Dip Testing: 100% positive at 10 mIU/mL hCG.
Cross-Reactivity	No false positives with related hormones (hLH, hFSH, hTSH)	No cross-reactivity observed with 1000 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 μIU/mL hTSH. Not affected by hCG β-core fragment up to 500,000 pmol/L.
Interference	No interference from common substances or urine properties	No interference observed at specified concentrations for various substances (Acetaminophen, Acetylsalicylic acid, Ascorbic acid, Atropine, Caffeine, Gentisic acid, Glucose, Hemoglobin, Tetracycline, Ampicillin, Albumin, β-hydroxybutyrate, Ephedrine, Phenylpropanolamine, Phenothiazine, EDTA, Salicyclic Acid, Benzoylecgonine, Cannabinol, Codeine, Ethanol, Bilirubin, Pregnanediol, Thiophene, Ketone). No effect from urine pH (4-9) or density (1.000-1.035).
Hook Effect	No hook effect up to clinically relevant high concentrations	No hook effect observed up to 500,000 mIU/mL hCG.
Clinical Agreement (vs. Predicate)	High agreement (e.g., >95%) with predicate device	Dip Testing: 100% conformity (49 Pos, 51 Neg vs Predicate). Midstream Testing: 100% conformity (48 Pos, 52 Neg vs Predicate).
Lay Person Readability & Interpretation	High agreement (e.g., >95%) between lay user and professional results; ease of use; clear labeling	In-Stream Method: 100% positive and 100% negative conformity with professional results (48 Pos, 52 Neg). Dip Method: 100% positive and 100% negative conformity with professional results (49 Pos, 51 Neg). Lay person results for spiked samples showed 98-100% agreement with professional results. Questionnaires indicated ease of use and clear labeling.
Early Detection Performance	Detect pregnancy early (e.g., 5 days before EMP)	Detected 67.7% positive hCG five days before the Expected Menstrual Period (EMP). Detected 100% positive hCG on the day of EMP.
Stability	Stable for a reasonable shelf life	24 months at 35.6-86°F (based on real-time stability study).

2. Sample Sizes and Data Provenance

Analytical Performance (Precision/Reproducibility/Sensitivity):
- Test Set Sample Size: For each hCG concentration (0, 3, 5, 7.5, 8, 10, 25, 50 mIU/mL), 10 replicates were tested per day for 5 days for each of 3 device lots, by 3 different operators. This sums to (8 concentrations * 10 replicates/day * 5 days * 3 lots) = 1200 tests for Midstream and another 1200 tests for Dip Testing.
- Data Provenance: Not explicitly stated, but typically these are laboratory-controlled, prospective studies with spiked samples. The hCG standard is traceable to the 5th WHO.
Specificity (Non-pregnant females):
- Test Set Sample Size: 300 urine samples (100 from pre-menopausal, 100 from peri-menopausal, 100 from post-menopausal women).
- Data Provenance: Not explicitly stated, but implies prospectively collected urine samples from healthy non-pregnant females.
Method Comparison Study (vs. Predicate):
- Test Set Sample Size: Urine samples from 200 women suspected to be pregnant in the early stage (<5 weeks).
- Data Provenance: Collected from women presenting to test for pregnancy, implying a prospective, clinical setting, likely in an unspecified country (as no country of origin is mentioned).
Lay Person Study:
- Test Set Sample Size: 200 women for self-testing. For spiked samples, 200 lay persons tested the samples.
- Data Provenance: Individuals with varying educational and occupational backgrounds from three sites. This is a prospective, user study.
Early Pregnancy Test Study:
- Test Set Sample Size: 650 urine samples from 65 pregnant women (65 characterized cycle segments of conceptive cycles).
- Data Provenance: Collected from pregnant women. This is a prospective, clinical study.

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

Analytical Performance: The ground truth for hCG concentrations was established by spiking negative urine with a known hCG standard (Traceable to the 5th WHO). No human experts were involved in establishing this ground truth, as it's an analytical measurement.
Specificity (Non-pregnant females): The ground truth was based on the healthy, non-pregnant status of the female participants. No specific experts or their qualifications for this judgment are mentioned, but it's assumed to be based on medical history or clinical assessment.
Method Comparison Study: The ground truth was the result obtained from the predicate device (Wondfo One Step HCG Urine Pregnancy Test Midstream/Strip/Cassette, K150022). No human experts were involved in establishing a separate ground truth.
Lay Person Study (vs. Professional Results): The "Professional Result" served as the ground truth. The qualifications of these "professionals" are not specified.
Early Pregnancy Test Study: The "Expected Menstrual Period (EMP)" and "pregnant women" served as the ground truth, implying clinical determination of pregnancy and cycle dating. No specific experts or their qualifications for this determination are mentioned.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1, 3+1) is mentioned for any of the studies.
For analytical performance, the ground truth was established by precise spiking of known concentrations.
For method comparison and lay person studies, direct comparison was made to the predicate device or "professional results" without specifying expert adjudication process if discrepancies arose.
For the early pregnancy test study, the ground truth seems to be clinical data (EMP, confirmed pregnancy) rather than expert review of the test results themselves.

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

No MRMC comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance.
This device is an Over-The-Counter (OTC) pregnancy test, where the "reader" is typically the lay user interpreting a digital display. The studies focused on the device's standalone performance, comparison to a predicate, and lay user comprehension/accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was done. The entire analytical performance section (sensitivity, hook effect, cross-reactivity, interfering substances) and the early pregnancy test study evaluated the device's technical performance to detect hCG and display a result ("Pregnant" or "Not Pregnant") without human interpretation beyond reading the digital display.
The "Professional Results" in the Lay Person study also reflect the device's standalone performance when used by trained individuals.

7. Type of Ground Truth Used

Analytical Performance: Known concentrations of hCG spiked into negative urine (traceable to WHO International Standard). This is an analytical gold standard.
Specificity: Healthy, non-pregnant status of study participants. This is an outcome/status-based ground truth related to the absence of the target analyte.
Method Comparison: Results from a legally marketed predicate device.
Lay Person Study: "Professional Results" using the Shinetell Plus™ device. This indicates a reference test ground truth, where the "professionals" are presumably highly accurate users.
Early Pregnancy Test Study: Clinically determined pregnancy and cycle dating relative to the Expected Menstrual Period (EMP). This is outcomes data/clinical status ground truth.

8. Sample Size for the Training Set

The document does not explicitly state a training set size or methodology for the Shinetell Plus™ Digital Early Pregnancy Test. This is common for this type of immunoassay device, which relies on established chemical and optical detection principles rather than machine learning algorithms that typically require large training datasets. The device's "learning" is inherent in its design and manufacturing.
The testing described is primarily for validation (verification and validation), not for training a predictive model.

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

As a training set is not explicitly mentioned or implied for an AI/machine learning model, this question is not directly applicable based on the provided document. The device operates on an immunoassay principle with "light reflection" and "photodiode" detection, suggesting a pre-programmed algorithm based on known HCG detection thresholds, rather than a learned model.

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K Number

K241978

Device Name

Shinetell Digital Pregnancy Test

Manufacturer

Hangzhou AllTest Biotech Co., Ltd.

Date Cleared

2024-08-13

(39 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K222305

Predicate For

N/A

Intended Use

ShinetellTM Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.

Device Description

Shinetell™ Digital Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format. Shinetell™ Digital Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.

AI/ML Overview

The provided document describes the Shinetell™ Digital Pregnancy Test, a device for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy, for over-the-counter use. The document focuses on demonstrating the device's performance characteristics and its substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the acceptance criteria and the study that proves the device meets these criteria:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate table, but the performance characteristics evaluated serve as the de facto criteria for demonstrating substantial equivalence. The key performance metrics and their reported results are:

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Sensitivity	Detection of hCG at specified concentrations (e.g., 25 mIU/mL) with high positive rates and low false positive rates at lower concentrations.	25 mIU/mL: 100% positive detection rate for both midstream and dip testing (overall 300/300 positive).12.5 mIU/mL: 0% positive detection rate (overall 0/300 positive).0 mIU/mL: 0% positive detection rate (overall 0/300 positive).The device demonstrated reproducible results, with operators and lots showing similar performance.
Hook Effect	No false negative results at very high hCG concentrations.	All tested concentrations (up to 500,000 mIU/mL) gave a positive result, demonstrating no hook effect.
Specificity/Cross-Reactivity	No false positive results from healthy non-pregnant females or cross-reactive substances. No interference from HCG ß-core fragment.	Non-pregnant females: 300 samples (100 from pre-menopausal, peri-menopausal, post-menopausal) tested by laypersons across both methods showed no false positives (100% negative).Cross-reactants: No cross-reactivity observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH at 0, 5, and 25 mIU/mL hCG spiked samples.hCG ß-core fragment: Performance not affected by concentrations up to 500,000 pmol/L.
Interfering Substances	Performance of the device is not affected by common interfering substances found in urine.	No interference effect observed with various substances at specified concentrations (e.g., Glucose 2000 mg/dL, Albumin 2000 mg/dL, Acetaminophen 20 mg/dL, etc.).Urine pH: Performance unaffected for pH 4-9.Urine Density: Performance unaffected for relative density 1.000-1.035.
Method Comparison (vs. predicate)	High conformity (agreement) between the new device and the predicate device.	Midstream method: 100% conformity (agreement) between the candidate and predicate devices (52 positive, 48 negative, total 100 cases).Dip method: 100% conformity (agreement) between the candidate and predicate devices (41 positive, 59 negative, total 100 cases).
Lay Person Study	High agreement between layperson results and professional results, and ease of use/understanding for lay users.	First Study (self-testing): 100% positive and 100% negative conformity between layperson self-tests and professional results for both midstream (N=100) and dip (N=100) methods.Second Study (blinded spiked samples): 100% correct results for laypersons testing 5 mIU/mL hCG (negative) and 25 mIU/mL hCG (positive) spiked samples. Questionnaire results indicated ease of use and understanding.

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

Analytical Performance (Precision/Sensitivity):
- Sample Size: For each hCG concentration (0, 12.5, 15, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 10 replicates were tested per day for 5 days for each of 3 device lots. With 3 operators, this resulted in 50 tests per operator per lot per concentration (10 replicates/day * 5 days), totaling 150 tests per concentration per lot.
- Overall Sensitivity Sample Size: For the sensitivity conclusions, the most critical concentrations (0, 12.5, 25, 50, 100, 200 mIU/mL) each had 300 tests (3 lots * 50 replicates * 2 methods, or summarized directly as 300 total results).
- Data Provenance: The document does not specify the country of origin for these spiked urine samples. It implies a laboratory setting for the spiking and testing, rather than patient samples. The study is retrospective in the sense that controlled samples were created for testing.
Specificity and Cross-Reactivity:
- Non-pregnant females: 300 samples (100 from each age group: pre-menopausal, peri-menopausal, post-menopausal).
- Cross-reactive substances/hCG ß-core fragment: Number of samples not explicitly stated per substance/concentration, but it involved "negative and positive female urine samples" spiked with the substances.
- Data Provenance: Not specified, but implied to be collected samples.
Interfering Substances:
- Number of samples not explicitly stated per substance/concentration, but involved "urine samples containing 0, 5 and 25 mIU/mL hCG" spiked with the substances.
- Data Provenance: Not specified, implied to be collected urine samples spiked in a lab setting.
Method Comparison Study:
- Sample Size: 200 women presenting to test for pregnancy, suspected to be pregnant (early stage, less than 5 weeks).
- Data Provenance: Retrospective, collected from patients at three Point-of-Care (POC) sites. Country of origin not specified.
Lay Person Study:
- First Study (self-testing): 200 women (individual pregnancy status self-tested).
- Second Study (blinded spiked samples): 100 laypersons for 5 mIU/mL hCG aliquots and 100 laypersons for 25 mIU/mL hCG aliquots.
- Data Provenance: "Individuals with varying educational and occupational backgrounds from three sites." Country of origin not specified. The first study used patient samples (their own urine); the second used controlled, spiked samples. Both are prospective in terms of the layperson testing event.

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

Analytical Performance (Precision/Sensitivity): Ground truth was established by the known concentration of hCG spiked into the negative urine samples, traceable to the 5th WHO International Standard. No human experts were used to interpret these results beyond confirming the digital readout.
Specificity, Cross-reactivity, Interfering Substances: Ground truth was established by the known negative status of the samples or the known spiked concentrations.
Method Comparison Study: The predicate device served as the "ground truth" for comparison. The study states "3 different professionals using the candidate device and 1 professional using the predicate device at each site." Their qualifications are not specified beyond "professionals."
Lay Person Study:
- First Study (self-testing): The "professional results" served as ground truth for comparison with layperson results. The qualifications of these "professionals" are not specified.
- Second Study (blinded spiked samples): The known spiked concentration (5 mIU/mL hCG meant to be negative, 25 mIU/mL hCG meant to be positive) acted as the ground truth. A "study administrator" was present to observe; their role was not to establish ground truth but to monitor the study.

4. Adjudication Method for the Test Set

The document does not describe a formal "adjudication method" involving multiple readers/experts to resolve discrepancies for the test sets.

For analytical performance, ground truth was by spiking, so no adjudication needed.
For method comparison and lay person studies, comparison was made against the predicate device results or professional results (in the case of actual patient samples). In the second layperson study, ground truth was by known concentration. Discrepancies (if any arose) or how they were handled (e.g., re-testing, exclusion) are not explicitly detailed.

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

No. This is a digital pregnancy test with a clear "Pregnant" or "Not Pregnant" readout, not an imaging device requiring human interpretation for complex diagnostic decisions. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess how human readers improve with AI vs. without AI assistance is not applicable to this device. The "human readers" (laypersons) are using the device to get a direct digital output, not making an interpretation with or without AI assistance.

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

Yes, in essence, the "Analytical Performance" section (Precision/Sensitivity, Hook Effect, Specificity, Interfering Substances) represents the standalone performance of the device, as it evaluates the device's ability to detect hCG at various concentrations and in the presence of challenging substances, independent of human interpretation variability. The digital output is the algorithm's direct result.

7. The Type of Ground Truth Used

The types of ground truth used varied depending on the performance characteristic being evaluated:

Known Spiked Concentrations: For sensitivity, hook effect, cross-reactivity (with defined interferers), and the second layperson study. This is a highly controlled, artificial ground truth.
Clinical (Patient) Samples with Known Status (or compared to predicate/professional): For method comparison study and the first layperson study. Here, the "ground truth" was either the result from the legally marketed predicate device or the result from a "professional" using the candidate device, implying a clinical assessment of the patient's pregnancy status (e.g., confirmatory lab tests, clinical history).

8. The Sample Size for the Training Set

The document does not provide information on the training set size because this is not an AI/ML device that requires a separate "training set" in the conventional sense. This is an immunoassay device with a digital readout mechanism based on light intensity detection. Its "design" is based on biochemical and optical principles, not on learned parameters from a large dataset. Therefore, there's no "training set" as would be seen for, say, an image-recognition AI algorithm.

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

As noted in point 8, there is no "training set" for this type of device in the context of an AI/ML algorithm. The device's operational parameters (e.g., thresholds for light intensity to display "Pregnant" or "Not Pregnant") are likely established during the device's development and internal validation processes using controlled, known concentrations of hCG, similar to the analytical performance testing described.

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K Number

K231698

Device Name

AllTest Fentanyl Rapid Test (Urine)

Manufacturer

Hangzhou AllTest Biotech Co., Ltd.

Date Cleared

2023-07-31

(49 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K220046

Predicate For

K233417,K242428

Intended Use

AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

Device Description

AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Rapid Test (Urine) device consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the AllTest Fentanyl Rapid Test (Urine), based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are generally inferred from the positive and negative agreement with the LC/MS reference method, especially around the cutoff concentration. While explicit numerical acceptance criteria are not stated as "acceptance criteria," the performance in the method comparison study demonstrates the device's ability to classify samples correctly.

Acceptance Criteria (Inferred)	Reported Device Performance (Aggregate from 3 Sites)
For Negative Samples (LC/MS < Cutoff): High agreement for definitively negative samples and samples below -50% of cutoff.	Negative Samples: 90/90 (100%) correctly identified as negative (Low Negative) 36/45 (80%) correctly identified as negative (Near Cutoff Negative)
For Positive Samples (LC/MS >= Cutoff): High agreement for definitively positive samples and samples above +50% of cutoff.	Positive Samples: 63/63 (100%) correctly identified as positive (High Positive) 65/69 (94.2%) correctly identified as positive (Near Cutoff Positive)
Overall Agreement with LC/MS: Demonstrate substantial equivalence to the predicate and accurate qualitative detection of fentanyl.	Overall Performance: See detailed breakdown in "Discordant Results" for samples around the cutoff. The device shows strong performance for samples well above or below the cutoff.
Precision: Consistent results across different lots and concentrations around the cutoff.	For -25% Cutoff: - Lot 1: 58-/2+ - Lot 2: 59-/1+ - Lot 3: 60-/0+ For Cutoff: - Lot 1: 35+/25- - Lot 2: 28+/32- - Lot 3: 26+/34- For +25% Cutoff: - All lots 60+/0-
Interference: No interference from common endogenous or exogenous substances at specified concentrations.	Over 80 tested compounds showed no interference at 100 µg/mL or specified concentrations (except Trazodone with 0.1% cross-reactivity).
Specificity (Cross-reactivity): Limited cross-reactivity with structurally similar compounds. Other opioids show no cross-reactivity.	Detailed cross-reactivity provided for 17 fentanyl analogs; 21 other opioid compounds showed no cross-reactivity.
Effect of Urine Specific Gravity and pH: Accurate results across a range of urine specific gravities and pH levels.	Consistent results (positive for +50% Cut-Off and above, negative for -50% Cut-Off and below) over specific gravity 1.000-1.035 and pH 4-9.

Study Details

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Operators ran 80 unaltered clinical samples at each of the three testing sites. This means a total of 240 tests were performed on the clinical samples (80 samples * 3 sites). Each sample was characterized by LC/MS results (40 negative and 40 positive for fentanyl).
Data Provenance: The document states "unaltered clinical samples." The country of origin is not specified, but the device manufacturer is based in Hangzhou, Zhejiang, China. The study appears to be prospective in the sense that the device was used to test these clinical samples, and the results were then compared to LC/MS.

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

Ground Truth Establishment: The ground truth for the test set was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug testing, rather than human experts.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as the ground truth was industrial standard LC/MS. Discordant results were identified by direct comparison to the LC/MS reference.

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

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly done. The study compares the device's performance against a gold standard (LC/MS), not against human readers with and without AI assistance. The device itself is an immunoassay, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Standalone Performance: Yes, the described method comparison study is a standalone (algorithm only without human-in-the-loop performance) study, as it evaluates the device's ability to detect fentanyl in urine samples independently and compares its results to LC/MS. Human operators ran the tests, but their interpretation was based on the test line development, which is an intrinsic function of the device's chemistry.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used was established by LC/MS/MS results, specifically for fentanyl concentration, with a cutoff of 1.0 ng/mL. LC/MS is a highly accurate and sensitive analytical chemistry technique considered the gold standard for confirming the presence and quantity of drugs in biological samples.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is an immunoassay and relies on chemical reactions, not on an algorithm that requires a training set. The various analytical performance studies (precision, interference, specificity) are internal validation studies that support the device's design and analytical capability, but these are not typically referred to as "training sets" in the same way as in AI/ML development.

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

Ground Truth for Training Set: Not applicable, as there is no explicitly defined "training set" for this immunoassay device in the context of AI/ML. All samples used in the analytical performance studies (precision, interference, specificity) involved prepared samples with known concentrations of fentanyl or interfering substances, often confirmed by LC/MS, or drug-free urine.

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K Number

K203272

Device Name

Alltest Pregnancy Rapid Combo Test Cassette

Manufacturer

Hangzhou AllTest Biotech Co., Ltd

Date Cleared

2022-01-31

(451 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

k132834

Predicate For

K241919

Intended Use

The Altest Pregnancy Rapid Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

Device Description

The Alltest Pregnancy Rapid Combo Test Cassette measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.

AI/ML Overview

The provided document is a 510(k) summary for the Alltest Pregnancy Rapid Combo Test Cassette, which is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. The device is intended for prescription use by healthcare professionals, including those at the point of care.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a separate section with predefined thresholds. Instead, it presents performance data from various studies. Based on the "Performance Characteristics" section, the implicit acceptance criteria are that the device should demonstrate:

High precision and accuracy around the cut-off values.
Stability over an extended period.
Specificity, with no significant interference from related hormones or common substances.
No high-dose hook effect.
Performance comparable to a legally marketed predicate device.

The reported device performance aligns with these implicit criteria, indicating successful validation.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision/Cut-Off	Establish accurate cut-off values (10 mIU/mL for serum, 20 mIU/mL for urine) with consistent positive/negative results across sites, lots, and operators.	* Serum: At 8 mIU/mL (below cut-off), 75.6% positive. At 10 mIU/mL (cut-off), 100% positive. At 0, 3, 5 mIU/mL, 100% negative. At concentrations >= 10 mIU/mL, 100% positive. * Urine: At 15 mIU/mL (below cut-off), 48.9% positive. At 17.5 mIU/mL (below cut-off), 80% positive. At 20 mIU/mL (cut-off), 100% positive. At 0, 5, 10 mIU/mL, 100% negative. At concentrations >= 20 mIU/mL, 100% positive. * Conclusion: Cut-off values of 10 mIU/mL for serum and 20 mIU/mL for urine are verified.
Stability	Demonstrate stability for an appropriate shelf life under specified storage conditions.	Stable at 2-30°C for 24 months based on an accelerated stability study at 55°C.
Specificity (High Dose Effect)	No hook effect at high hCG concentrations.	No hook effect observed with hCG concentrations ranging from 500 to 2,000,000 mIU/mL.
Specificity (ß-core fragment)	No significant interference from hCG ß-core fragment up to certain concentrations.	No interference observed except for false positives above 100 pmol/L ß-core fragment hCG. (Note: The document doesn't provide the expected range of ß-core fragment in actual samples or how this level of interference compares to clinical relevance, but states "No difference was observed for different lots and different operators.")
Specificity (Glycoprotein Hormones)	No interference from LH, FSH, TSH at physiological/elevated levels.	No interference observed at LH concentrations up to 500 IU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 uIU/mL.
Interference (Common Substances)	No interference from a specified list of common exogenous and endogenous substances at given concentrations.	All tested compounds (Acetaminophen, Acetoacetic Acid, Ascorbic Acid, Atropine, Acetosalicylic Acid, Albumin, Bilirubin, Caffeine, Codeine, Ephedrine, EDTA, Ethanol, Gentisic Acid, Glucose, Hemoglobin, Methadone, Phenylpropanolamine, Phenothiazine, Pregnanediol, Salicylic Acid, ß-hydroxybutyrate, Benzoylecgonine, Cannabinol, Methanol, Estriol-17-beta, Thiophene, Ampicillin, Tetracycline, Ketone, Total cholesterol, Triglycerides, High-density lipoprotein) showed no interference at the stated concentrations for both negative and positive hCG samples.
Effect of Urine Specific Gravity & pH	No interference across physiological/pathological ranges of urine specific gravity and pH.	No interference from pH ranging from 4 to 9 and specific gravity ranging from 1.001 to 1.035.
Method Comparison	Demonstrate substantial equivalence (high agreement) with a legally marketed predicate device.	* Urine: 100% agreement between the new device and the predicate (53 positive, 52 negative). * Serum: 100% agreement between the new device and the predicate (58 positive, 49 negative).

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

Precision/Reproducibility/Cut-Off Value Study:
- Test Set Size (Serum): 90 replicates for each hCG concentration level (3 sites x 30 replicates per concentration). In total, 9 concentrations were tested, so 90 x 9 = 810 tests.
- Test Set Size (Urine): 90 replicates for each hCG concentration level (3 sites x 30 replicates per concentration). In total, 9 concentrations were tested, so 90 x 9 = 810 tests.
- Data Provenance: Not explicitly stated, but the testing was conducted at "three testing sites" by "six different operators." It's likely these were internal or contract labs, possibly within China (where the manufacturer is located) or the US (where the submitter's contact is). The data is from controlled experimental studies.
- Retrospective/Prospective: Prospective (experimental spiking of samples).
Method Comparison Study:
- Test Set Size (Urine): 105 urine samples.
- Test Set Size (Serum): 107 serum samples.
- Total Test Set Size: 212 samples (from 212 women).
- Data Provenance: Samples collected from 212 women from "three testing sites." Ages ranged from 20 to 49 years. "About half of them were pregnant, early stage at less than 5 weeks." Not explicitly stated, but implies clinical samples used for comparison. The country of origin is not specified.
- Retrospective/Prospective: Likely prospective clinical sample collection for the purpose of the study.
Other Analytical Performance Studies (Specificity, Interference, pH/Specific Gravity):
- Sample sizes vary but generally involve spiking negative and positive samples with various concentrations of the interferent/condition and testing with 3 different lots by 3 different operators. Exact total sample counts for each condition are not explicitly provided but involve multiple replicates across lots and operators.
- Data Provenance: Controlled experimental studies with spiked samples.
- Retrospective/Prospective: Prospective (experimental spiking of samples).

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

Precision/Reproducibility/Cut-Off Value Study: The "ground truth" for the test set was established by precisely spiking known concentrations of hCG (traceable to the 5th WHO international Standard) into negative serum or urine specimens. This is an analytical truth rather than an expert interpretation. Six different operators performed these tests; their qualifications are not specified but would typically be laboratory technicians.
Method Comparison Study:
- The "ground truth" for the comparison study was the result obtained from the predicate device (K132834, Clarity Diagnostics Clarity hCG Pregnancy Combo Test Cassette). This means the predicate device itself served as the reference standard, and the new device's agreement was measured against it.
- There is no mention of independent experts establishing a "true" pregnancy status. The comparison is between two devices.
- The tests were performed by "different health professionals," but their specific number or qualifications (e.g., radiologist with 10 years of experience) are not provided.

4. Adjudication Method for the Test Set

Precision/Reproducibility/Cut-Off Value Study: No adjudication method as the ground truth was analytically determined (spiked concentrations). Results were recorded and analyzed statistically.
Method Comparison Study: No adjudication method mentioned for comparing the predicate and new device results against a separate "true" outcome. The comparison itself uses the predicate device as the reference.

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

No. This document describes the performance of an in-vitro diagnostic (IVD) test, not an imaging device or AI-powered diagnostic that would typically involve human readers interpreting cases with and without AI assistance. Therefore, an MRMC comparative effectiveness study was not performed, and there is no effect size reported for human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The studies present the analytical performance of the device itself (the "algorithm" or immunoassay), reporting its ability to detect hCG in various conditions. While "health professionals" perform the tests, the core performance characteristics (sensitivity, specificity, cut-off accuracy, interference) are inherent to the device's design and chemical reactions, operating in a standalone manner once the sample is applied. The "Method Comparison Study" directly evaluates the standalone performance of the device against another device.

7. Type of Ground Truth Used

Analytical Studies (Precision, Specificity, Interference, pH/Specific Gravity): The ground truth was based on known, precisely controlled concentrations of hCG, interferents, or specific pH/gravity conditions, established through spiking or preparing samples. This is a form of analytical truth.
Method Comparison Study: The ground truth for this study was the results obtained from a legally marketed predicate device. The predicate device's results were accepted as the reference against which the new device was compared.

8. Sample Size for the Training Set

This document primarily describes analytical validation and comparison studies. For an IVD device like this, there isn't typically a "training set" in the machine learning sense. The device's performance is driven by its biochemical design and manufacturing process, not trained on data. Development may involve iterative testing and refinement, but a formal "training set" size as understood in AI/ML is not applicable or provided here.

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

As noted above, a "training set" in the context of AI/ML is not applicable for this type of immunoassay device. The device's operational parameters (like antibody conjugates, membrane properties, and cut-off thresholds) are established through research, development, and analytical validation studies, not by training on a labeled dataset.

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K Number

K182738

Device Name

Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)

Manufacturer

Hangzhou AllTest Biotech Co., Ltd

Date Cleared

2019-03-27

(180 days)

Product Code

DKZ,DIO,DIS,DJC,DJG,DJR,DNK,JXM,LAF,LCM,LDJ,LFG,NFT,NFV,NFW,NFY,NGG,NGI,NGL,NGM,PTG,PTH,QAW

Regulation Number

862.3100

Type

Traditional

Panel

Toxicology

Reference & Predicate Devices

k173303

Predicate For

K233019

Intended Use

The Single and Multi-Drug Rapid Test Cup With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.