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510(k) Data Aggregation
(494 days)
Clearblue**®** Early Digital Pregnancy Test
The Clearblue® Early Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This digital 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.
The test is intended for home use.
The Clearblue® Early Digital Pregnancy Test is an over-the-counter (OTC), digital pregnancy test with sensitivity to 10mIU/ml hCG (hormone human chorionic gonadotrophin) and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip. The result is displayed to the user, in words, on an LCD.
The Clearblue® Early Digital Pregnancy Test is an over-the-counter chromatographic immunoassay designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended as an aid in the early detection of pregnancy, up to six days before a missed period.
Here's the breakdown of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a bulleted or numbered list with predefined thresholds. Instead, the performance characteristics are presented as evidence of the device's capability and equivalence to a predicate device. Based on the provided data, the implied acceptance criteria would revolve around:
- Analytical Sensitivity: Ability to detect hCG at a specified concentration (e.g., 10 mIU/ml).
- Analytical Cut-off: The hCG concentration at which approximately half of the devices yield positive results.
- Specificity: No significant interference from common substances or cross-reactivity with related hormones.
- Lay User Performance: High agreement with clinical pregnancy status and technician results when used by laypersons.
- Early Detection Claim: Demonstrated detection rates at various days relative to the missed period.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity | Detect hCG at 10 mIU/ml with high accuracy (e.g., 100% positive) | 100% positive results at 10 mIU/ml hCG concentration (both dip and simulated in-stream methods across technicians and days). |
| Analytical Cut-off | To be determined and reported. | Determined as 7.6 mIU/ml. |
| Interfering Substances | No interference at specified concentrations. | No interference observed at tested concentrations for various substances (e.g., Acetylsalicylic acid, Acetone, Albumin, Glucose, Haemoglobin, etc.) up to 10 mIU/ml hCG. |
| Cross-reactivity | No cross-reactivity with specified hormones. | No cross-reactivity observed at tested concentrations for Follicle-Stimulating Hormone (FSH) (1000 mIU/ml), Luteinizing Hormone (LH) (500 mIU/ml), and Thyroid-Stimulating Hormone (TSH) (1 mIU/ml). |
| Effect of Urine pH | Correct results across physiological pH range. | Correct results observed within a pH range of 4-9. |
| Effect of Urine Specific Gravity | Correct results across physiological specific gravity range. | Correct results observed within a specific gravity range of 1.000 to ≤1.035. |
| Effect of hCG beta core fragment | Performance not affected by high concentrations. | Performance not affected by high concentrations of hCG β-core fragment. |
| Method Comparison with Predicate | High agreement with predicate device and clinical status. | 99.5% agreement with the FIRST RESPONSE™ Gold Digital Pregnancy Test. 100% agreement with the clinical status of volunteers' urine samples. |
| Early Pregnancy Detection | Detection rates supporting early claim (e.g., 6 days before MPs). | Shows varied detection rates: 78.4% at -6 days, 93.1% at -5 days, 99.0% at -4 days, and 100.0% from -3 to -1 days relative to the missed period. (Claim: as early as six days before the missed period). |
| Lay User Study Performance | High Positive Predictive Value (PPV), Negative Predictive Value (NPV), Sensitivity, Specificity, and Accuracy. High agreement between lay-user results, clinical status, and technician results. | 100% PPV, NPV, sensitivity, specificity, and accuracy when used by lay users, for both dip and in-stream testing methods, compared to clinical pregnancy status. 100% agreement between lay-user volunteer results (in-stream vs dip) and clinical status. 100% agreement between all lay-user volunteer results and technician dip results. |
| Specificity (False-Positive Rate) | Low false-positive rate across age cohorts. | 100.0% specificity for pre-menopausal and peri-menopausal women. 99.3% specificity for post-menopausal women (1 false positive out of 150 attributed to an hCG concentration of 7.83 mIU/ml, which is above the analytical cut-off). Overall specificity: 99.8% (449/450). |
| Lay User Spiked Standard Study (Detection Rates) | Detect 10 mIU/ml hCG with 100% accuracy, graded detection below that. | 100% detection at 10 mIU/ml. 74% detection at 8.5 mIU/ml. 50% detection at 7.5 mIU/ml. 0% detection at 3 mIU/ml. |
2. Sample Sizes and Data Provenance
- Test Set for Analytical Performance (Precision/Reproducibility):
- Sample Size: For each of the nine hCG standards, 324 total samples were tested (162 with dip method, 162 with simulated in-stream method). This was further broken down by technicians and days (e.g., 108 samples per technician/day for each standard).
- Data Provenance: Not explicitly stated, but implies laboratory-prepared spiked urine samples. No country of origin is specified, but the applicant addresses are in Switzerland and the UK. This is prospective for the test devices.
- Test Set for Method Comparison with Predicate Device:
- Sample Size: 102 urine samples from pregnant women and 102 urine samples from non-pregnant women.
- Data Provenance: Not explicitly stated, but refers to "urine samples from pregnant women" and "not pregnant women," suggesting retrospective clinical samples or samples collected for the study. No country of origin for samples is specified.
- Test Set for Early Pregnancy Detection (Clinical Samples):
- Sample Size: 831 early pregnancy urine samples from days -10 to -1 relative to the day of the missed period.
- Data Provenance: Clinical samples. No country of origin is specified.
- Test Set for Lay User Study (Clinical Samples):
- Sample Size: 394 volunteers (205 not pregnant, 189 pregnant).
- Data Provenance: Volunteers. No country of origin is specified.
- Test Set for Specificity Study (False-positive rate):
- Sample Size: 450 urine samples (150 from pre-menopausal, 150 from peri-menopausal, 150 from post-menopausal women).
- Data Provenance: Clinical samples. No country of origin is specified.
- Test Set for Lay User Spiked Standard Study:
- Sample Size: 200 samples per hCG standard (3, 7.5, 8.5, 10 mIU/ml), totaling 800 samples.
- Data Provenance: Laboratory-prepared spiked urine samples, tested by lay users. No country of origin is specified.
3. Number of Experts and Qualifications for Ground Truth
- For Analytical Performance (Precision/Reproducibility): 3 technicians performed the testing. Their specific qualifications are not detailed beyond "trained technicians."
- For Method Comparison with Predicate Device: "Trained technicians" performed the testing.
- For Early Pregnancy Detection (Clinical Samples): There is no mention of experts establishing ground truth for these samples, but it's implied that the "Days Relative to Missed Period" serves as the clinical ground truth for assessing early detection.
- For Lay User Study: Technician results via dip method and the "clinical pregnancy status" of the volunteers served as ground truth. The qualifications of these technicians are not explicitly stated, but their role suggests expertise in properly performing and interpreting the test.
- For Specificity Study: Technicians performed the testing. The "clinical status" of the non-pregnant women was the ground truth.
- For Lay User Spiked Standard Study: Lab-prepared hCG standards define the ground truth.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for any of the studies. All results appear to be direct observations or comparisons to established clinical status or laboratory standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was done. The device is a standalone in-vitro diagnostic (IVD) device, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
Yes, a standalone performance study (algorithm only, without human-in-the-loop performance) was performed. The "Analytical Performance" section, particularly the Precision/Reproducibility study, evaluates the device's ability to detect hCG at various concentrations independently. The results obtained by technicians also represent the device's standalone performance, albeit with trained human operation. The "Lay User Studies" also assess the device's performance when used by the intended end-user, essentially as a standalone OTC product.
7. Type of Ground Truth Used
- Analytical Performance (Precision/Reproducibility, Spiked Standard Studies): Laboratory-prepared hCG spiked urine standards (known concentrations of hCG).
- Method Comparison with Predicate Device: Clinical status (pregnant/not pregnant) of urine samples and comparison with a legally marketed predicate device.
- Early Pregnancy Detection (Clinical Samples): Days relative to the missed period (biological/clinical stages of pregnancy).
- Lay User Study: Clinical pregnancy status of the volunteers and technician-performed test results.
- Specificity Study: Clinical status (non-pregnant) of women from different age cohorts.
8. Sample Size for the Training Set
The document describes performance studies for analytical and clinical validation. It does not provide information about a "training set" in the context of machine learning or AI development. This device is a chromatographic immunoassay, not an AI/ML-based device that typically requires a distinctive training set.
9. How the Ground Truth for the Training Set Was Established
As noted above, the device is not an AI/ML-based device, so the concept of a "training set" and associated ground truth establishment is not applicable in this context. The various studies used laboratory standards or clinical status as their ground truth for evaluation.
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