(2 days)
CLINITEK® hCG Test Strips are for the qualitative measurement of Human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. CLINITEK hCG Test Strips are for professional use in clinical laboratories, physician offices and other point-of-care healthcare locations.
CLINITEK® hCG Test Strips are unitized reagent strips used with the CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers. Each bottle contains 25 test strips.
Here's an analysis of the provided text regarding the CLINITEK® hCG Test Strips, structured according to your request. Please note that the provided text is a "510(k) Safety and Effectiveness Summary" and thus focuses on demonstrating equivalence to predicate devices rather than a detailed scientific publication. As such, some specific details you requested (like exact sample sizes for training/test sets or detailed ground truth establishment for all cases) may not be fully explicit in this summary.
Acceptance Criteria and Device Performance for CLINITEK® hCG Test Strips
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical "acceptance criteria" in the form of specific sensitivity and specificity thresholds. Instead, it states that the performance was "assessed according to the FDA Reviewer's Guidance Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVD's)" and "Chorionadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application" (NCCLS guideline). The conclusion is that the device is "equivalent in performance to predicate devices."
Therefore, the "acceptance criteria" can be inferred as meeting the performance standards (sensitivity, specificity, accuracy) demonstrated by the predicate devices and established by the FDA and NCCLS guidelines for hCG IVDs. Since specific numerical performance metrics are not given for the CLINITEK® hCG Test Strips in this summary, the table will reflect this by stating the reported equivalence rather than specific values.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Performance equivalent to predicate devices (QuickVue® One-Step HCG Combo and Test Pack +Plus hCG Combo) as per FDA & NCCLS guidelines for hCG IVDs. | "Equivalent in performance to predicate devices currently in interstate commerce." |
| Suitable for professional use in clinical laboratories, physician offices, and other point-of-care healthcare locations. | "Suitable for use in point-of-care locations." |
2. Sample Sizes and Data Provenance for Test Set
- Sample Size for Test Set: The document mentions "Studies were performed in-house and in external field evaluations utilizing clinical urine specimens." However, it does not specify the exact sample size for these evaluations.
- Data Provenance: The data was collected from "clinical urine specimens." The location of these collections is not explicitly stated beyond "in-house and in external field evaluations," implying a mix of internal (Bayer Corporation) and external (presumably clinical sites) sources. It can be inferred that these were prospective collections for the purpose of the study, as they describe performance assessment through evaluations.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). For immunoassay devices like this, ground truth is typically established using a reference method (e.g., a highly sensitive laboratory-based quantitative hCG assay) rather than expert consensus on visual interpretation.
4. Adjudication Method for Test Set
The document does not describe an adjudication method involving multiple readers for interpreting the test results. Given that the device is an instrumental reader (CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers) that outputs "positive" or "negative," human adjudication of the device's output would not typically be required. Adjudication would more likely apply to discordant results between the device and the reference method, but this detail is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
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Was a MRMC study done? No, a MRMC comparative effectiveness study was not mentioned or implied. This type of study is more relevant for diagnostic aids where human interpretation is a critical part of the workflow and the AI is designed to assist that interpretation. The CLINITEK® hCG Test Strips are read instrumentally, not by human visual interpretation.
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Effect size of human readers improve with AI vs. without AI assistance: Not applicable, as there's no human-in-the-loop AI assistance described for this device's operation. The "AI" here is the instrument's algorithm converting reflectance to a positive/negative result.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study (algorithm only) was done. The "Assessment of Performance" describes evaluations of the CLINITEK® hCG Test Strips being read instrumentally by the CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers. The instruments "analyze the color and intensity of the light reflected from the test strip" and convert "measured reflectance and displays the results as either 'positive' or 'negative'". This describes the algorithm's direct output without human intervention for interpretation.
7. Type of Ground Truth Used
The text implies that the ground truth was established using reference methods for hCG detection. The adherence to FDA and NCCLS guidelines for hCG IVDs strongly suggests that these studies would compare the device's results against a highly reliable, perhaps quantitative, laboratory method for hCG detection, which would serve as the "gold standard" or ground truth. It is unlikely to be solely expert consensus (as it's an objective measurement) or outcomes data (as it's an in vitro diagnostic).
8. Sample Size for the Training Set
The document does not specify the sample size used for training the instrument's algorithm. For a device approved in 1997, the "training" of such algorithms (which convert reflectance to positive/negative) would likely involve calibration and standardization processes using a range of known positive and negative samples, rather than a large "deep learning" style training set as understood today.
9. How the Ground Truth for the Training Set Was Established
Similar to the test set, the ground truth for any "training" or calibration would have been established using reference methods for hCG detection (e.g., known concentrations of hCG in urine, likely confirmed by a highly accurate quantitative laboratory assay). This would ensure that the instrument's algorithm was correctly calibrated to differentiate between positive and negative hCG levels according to clinical thresholds.
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Baver Corporation, Business Group Diagnostics CLINITEK® hCG Test Strips
510(k) Safety and Effectiveness Summary Page 1 of 2
CLINITEK® hCG Test Strips for
510(k) SAFETY AND EFFECTIVENESS SUMMARY
March 12, 1997 Prepared:
Submitter: Bayer Corporation, Business Group Diagnostics
- 1884 Miles Avenue, P. O. Box 70 Address: Elkhart, IN 46515 (219) 262-6929
- Rosanne M. Savol, R.A.C. Contact: Manager, Regulatory Affairs
- Device:
Detection of hCG in Urine Common/Usual Name: Urine Pregnancy Test Document Control Number: K97
Classification Name: Human Chorionic Gonadotropin (hCG) Test System
Trade/Proprietary Name:
- Predicate Devices: OuickVue® One-Step HCG Combo Manufactured by QUIDEL Corporation Test Pack +Plus hCG Combo Manufactured by Abbott Laboratories
- CLINITEK® hCG Test Strips are unitized reagent strips used with the Device Description: CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers. Each bottle contains 25 test strips.
- CLINITEK® hCG Test Strips are for the qualitative measurement of Intended Use: Human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. CLINITEK hCG Test Strips are for professional use in clinical laboratories, physician offices and other point-of-care healthcare locations.
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Technological Characteristics:
The CLINITEK® hCG Test Strip uses immunochromatographic assay methods for detecting human chorionic gonadotropin (hCG) in urine. It is intended to be read instrumentally on the CLINITEK 50 and CLINITEK 100 Urine Chemistry Analyzers. The first zone of the test strip contains antibody to hCG (monoclonal anti-beta hCG) coupled with red dye. The urine rehydrates this zone and mobilizes the antibody-dye. Any hCG present will bind with the antibody-dye conjugate. Another zone of hCG specific antibodies (polyclonal anti-alpha hCG) is bound to the strip. As the hCGantibody-dye moves along the strip it will bind to this zone producing a red line (positive result). A similar migration pattern occurs with the built-in procedural control feature. A blue line appears which indicates that a sufficient amount of urine has saturated the test strip. If there is no hCG present in the urine only the blue line will appear (negative result). The CLINITEK 50 and CLINITEK 100 Urine Chemistry Analyzers are relectance photometers that analyze the color and intensity of the light reflected from the test strip. The algorithm in the instruments converts the measured reflectance and displays the results as either "positive" or "negative" on the instrument display panel. No calculations are required by the user.
Assessment of Performance:
The performance of CLINITEK® hCG Test Strips was assessed according to the FDA Reviewer's Guidance Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVD's) and the National Committee for Clinical Laboratory Standards (NCCLS) guideline Chorionadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application Studies were performed in-house and in external field evaluations utilizing clinical urine specimens.
Conclusion:
The results of the internal and external studies demonstrate that CLINITEK® hCG Test Strips are equivalent in performance to predicate devices currently in interstate commerce and suitable for use in point-of-care locations.
' Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVD's). Department of Health and Human Services, Food and Drug Administration. CDRH, 2098 Gatther Road, Rockville, MD 20850, 1995.
2 Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Proposed Guideline. National Committee for Clinical Laboratory Standards (NCCLS) Document I/LA10-P (ISBN 1-56238-275-6). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087, 1995.
§ 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.