(121 days)
The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is only intended for prescription use in clinical laboratories and is not intended for point-of-care use settings.
Fastep S10 hCG Serum/Urine Combo Test 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 devices are in two different formats: Strip, Cassette.
The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens, intended as an aid in early detection of pregnancy. It is for prescription use in clinical laboratories and not for point-of-care use.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Precision/Reproducibility/Cut-Off Value (Serum Strip) | High agreement at 0 mIU/mL and at/above cut-off (10 mIU/mL), with some variability expected near the cut-off. | 0 mIU/mL: 100% agreement (90 negative results across 3 lots). |
| 8 mIU/mL (below cut-off): 91% agreement (25 "negative", 5 "positive"). | ||
| 9 mIU/mL (below cut-off): 71% agreement (16 "negative", 14 "positive"). | ||
| 10 mIU/mL (cut-off): 97% agreement (3 "negative", 87 "positive"). | ||
| 12 mIU/mL - 150 mIU/mL (above cut-off): 100% agreement (all positive). | ||
| Precision/Reproducibility/Cut-Off Value (Serum Cassette) | High agreement at 0 mIU/mL and at/above cut-off (10 mIU/mL), with some variability expected near the cut-off. | 0 mIU/mL: 100% agreement (90 negative results across 3 lots). |
| 8 mIU/mL (below cut-off): 90% agreement (27 "negative", 3 "positive"). | ||
| 9 mIU/mL (below cut-off): 74% agreement (20 "negative", 10 "positive"). | ||
| 10 mIU/mL (cut-off): 96% agreement (4 "negative", 86 "positive"). | ||
| 12 mIU/mL - 150 mIU/mL (above cut-off): 100% agreement (all positive). | ||
| Precision/Reproducibility/Cut-Off Value (Urine Strip) | High agreement at 0 mIU/mL and at/above cut-off (20 mIU/mL), with some variability expected near the cut-off. | 0 mIU/mL: 100% agreement (90 negative results across 3 lots). |
| 16 mIU/mL (below cut-off): 88% agreement (26 "negative", 4 "positive"). | ||
| 18 mIU/mL (below cut-off): 66% agreement (10 "negative", 20 "positive"). | ||
| 20 mIU/mL (cut-off): 96% agreement (4 "negative", 86 "positive"). | ||
| 22 mIU/mL - 250 mIU/mL (above cut-off): 100% agreement (all positive). | ||
| Precision/Reproducibility/Cut-Off Value (Urine Cassette) | High agreement at 0 mIU/mL and at/above cut-off (20 mIU/mL), with some variability expected near the cut-off. | 0 mIU/mL: 100% agreement (90 negative results across 3 lots). |
| 16 mIU/mL (below cut-off): 80% agreement (18 "negative", 12 "positive"). | ||
| 18 mIU/mL (below cut-off): 57% agreement (13 "negative", 17 "positive"). | ||
| 20 mIU/mL (cut-off): 98% agreement (2 "negative", 88 "positive"). | ||
| 22 mIU/mL - 100 mIU/mL (above cut-off): 100% agreement (all positive). | ||
| Stability | Stable at specified temperature ranges for the stated duration. | Stable at 4-30°C for 24 months based on accelerated stability study at 50°C and real-time stability determination at 4°C and 30°C. |
| Specificity / Cross Reactivity | No hook effect at high hCG concentrations. No significant interference from hCG B-core fragment, LH, FSH, and TSH at specified concentrations. | High Dose Effect: No hook effect observed up to 2,000,000 mIU/mL hCG. |
| Effects of hCG B-core fragment: Interference observed at 500 pmol/L and above for hCG-free samples; no interference for samples spiked with 10mIU/mL hCG (serum) or 20mIU/mL hCG (urine). | ||
| Effects of glycoprotein LH, FSH, and TSH: No interference observed at tested concentrations (LH 300mIU/mL, FSH 1000mIU/mL, TSH 1000µIU/mL) for negative and positive hCG samples (0, 10, 20 mIU/mL). | ||
| Interference | No interference from common exogenous compounds at stated concentrations. | All listed compounds (Acetaminophen, Acetoacetic Acid, Ascorbic Acid, B-hydroxybutyrate, Caffeine, Ephedrine, Gentisic Acid, Phenylpropanolamine, Salicylic Acid, Phenothiazine, EDTA, Acetylsalicylic Acid, Benzoylecgonine, Cannabinol, Codeine, Ethanol, Methanol, Albumin, Glucose, Bilirubin, Atropine, Estriol-17-beta, Hemoglobin, Pregnanediol, Thiophene, Ampicillin, Tetracycline, Ketone) showed no interference in both hCG-free and hCG-positive samples at the stated concentrations, for both 3-minute and 10-minute read times. |
| Effect of Urine Specific Gravity and pH | No interference from varying urine specific gravity and pH. | pH: No interference observed for urine samples with pH from 4 to 9 in both negative and positive (20 mIU/mL hCG) samples. |
| Specific Gravity: No interference observed for urine samples with specific gravity from 1.000 to 1.035 in both negative (5 mIU/mL hCG) and positive (20 mIU/mL hCG) samples. | ||
| Comparison Studies | High agreement (e.g., >95% for positive, 100% for negative) with a legally marketed predicate device. | "The study result shows that over 95% agreements for positive samples, and 100% agreement for negative samples." (This general statement applies to all four comparison tables: Urine Strip, Urine Cassette, Serum Strip, Serum Cassette, though the tables themselves have corrupted data). |
2. Sample size used for the test set and the data provenance:
- Precision/Reproducibility/Cut-Off Value Studies:
- For serum (strip and cassette formats): 15 hCG concentrations were tested. For each concentration, 10 replicates were measured for 3 different lots, by 3 different operators, in 2 runs per day for 5 days. This sums to
10 replicates * 3 lots * 3 operators * 2 runs * 5 days = 900 testsper hCG concentration. The results tables show30 results (10 replicates x 3 operators)per lot, and thus90 resultsper hCG concentration across the 3 lots. - For urine (strip and cassette formats): Similar to serum, 15 hCG concentrations were tested. For each concentration, 10 replicates were measured for 3 different lots, by 3 different operators, in 2 runs per day for 5 days. This sums to
10 replicates * 3 lots * 3 operators * 2 runs * 5 days = 900 testsper hCG concentration. The results tables show30 results (10 replicates x 3 operators)per lot, and thus90 resultsper hCG concentration across the 3 lots. - Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be clinical laboratory settings given the intended use. These were spiked samples, not naturally occurring patient samples.
- For serum (strip and cassette formats): 15 hCG concentrations were tested. For each concentration, 10 replicates were measured for 3 different lots, by 3 different operators, in 2 runs per day for 5 days. This sums to
- High Dose Effect Study: Spiked negative urine/serum samples with 7 different high hCG concentrations. Tested by 3 different lots and 3 different operators. The number of replicates per concentration is not specified but the table shows a consistent positive result.
- Effects of hCG B-core fragment Study: Serum samples with 0mIU/mL and 10mIU/mL hCG were spiked with 14 different concentrations of B-core fragment. Urine samples with 0mIU/mL and 20mIU/mL hCG were spiked with the same B-core fragment concentrations. Tested by 3 different lots and 3 different operators. Number of replicates not specified.
- Effects of glycoprotein LH, FSH and TSH Study: Negative and positive samples (0 and 20 mIU/mL hCG for urine, 0 and 10 mIU/mL hCG for serum) were spiked with various concentrations of LH, FSH, and TSH. Tested by 3 different lots and 3 operators. Number of replicates not specified.
- Interference Study: Each of 19 interferents was spiked into hCG-free and hCG-positive (10mIU/mL for serum, 20mIU/mL for urine) samples. Each spiked sample was tested using 3 different lots of the kit. Number of replicates not specified but results for all 3 lots are shown.
- Effect of Urine Specific Gravity and pH Study: Urine samples (negative and positive at 20 mIU/mL hCG) tested at 6 pH values (4-9). Urine samples (negative and positive at 5 and 20 mIU/mL hCG) tested at 5 specific gravity values (1.000-1.035). Tested using 3 different lots by 3 different operators. Number of replicates not specified.
- Comparison Studies:
- 100 urine samples and 100 serum samples were collected from 100 women.
- Data Provenance: Not explicitly stated (e.g., country of origin). The samples were "collected from 100 women (about half of them were pregnant, early stage at less than 5 weeks)." This suggests prospective collection for the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Precision/Reproducibility/Cut-Off Value Studies: The "ground truth" (i.e., expected positive/negative based on hCG concentration) was established by using commercially available hCG traceable to the 4th WHO international Standard. These were spiked samples, so the hCG concentration was known.
- Comparison Studies: Ground truth for the 100 urine and 100 serum samples was established by the "results from predicate devices (QVUE)". It's not explicitly stated that experts established the ground truth for these samples; rather, the predicate device served as the reference.
- Other Studies (Specificity, Interference, pH/Specific Gravity): Ground truth was based on the known spiked concentrations of hCG or interferents.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Precision/Reproducibility/Cut-Off Value Studies, High Dose Effect, hCG B-core fragment, Glycoprotein hormones, Interference, pH/Specific Gravity: Data was collected by 3 different operators for each lot. The tables show the results from each individual lot, and then an "Overall Agreement" is calculated based on the total number of negative/positive results across the 3 lots. There is no explicit mention of an adjudication process (e.g., if operators disagreed).
- Comparison Studies: "Samples were tested by three different health professionals with the proposed and the predicate devices." It is not stated how discrepancies between the health professionals were resolved or if their readings were adjudicated. The summary tables combine results, implying an agreement or average.
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, this is not an MRMC comparative effectiveness study involving AI. It is a comparison study between a new device and a predicate device, using human readers for both. Therefore, no effect size of human readers improving with or without AI assistance is reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this device is a rapid visual immunoassay (test strip/cassette) intended to be interpreted visually by human users ("health professionals"). There is no algorithm or AI component, and thus no standalone algorithm-only performance was conducted or is applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For analytical performance metrics (precision, specificity, interference, pH/specific gravity), the ground truth was based on known spiked concentrations of hCG, interferents, or controlled pH/specific gravity levels. This is essentially a controlled laboratory standard.
- For the comparison studies, the ground truth was established by the predicate device (QuickVue One-Step hCG Combo test).
8. The sample size for the training set:
This device is not an AI/ML algorithm, so there is no "training set" in the conventional machine learning sense. The performance data presented are for verification and validation of the device's analytical and clinical performance.
9. How the ground truth for the training set was established:
As there is no AI/ML component, there is no "training set" or ground truth for a training set.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.