(23 days)
The RapidVue hCG test is an immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by health care professionals.
The RapidVue hCG test uses a monoclonal antibody specific to the beta subunit of hCG in a single-step technology to accurately detect hCG. The Dipstick is dipped in urine. If hCG is present in the specimen at a level of 25 mlU/mL or greater, a pink-to-red Test (T) Line will appear along with a blue procedural Control (C) Line in the test result area. If hCG is present at lower levels, or not present in the specimen, only a blue procedural Control Line will appear in the test result area.
The provided text describes the RapidVue hCG test, an immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for early pregnancy detection. The submission aims to demonstrate substantial equivalence to the predicate device, QuickVue One-Step hCG Urine Test (K020799).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a pass/fail threshold. Instead, it describes performance characteristics that the RapidVue hCG test aimed to demonstrate as being "consistent with" or "substantially equivalent" to the predicate device. For the purpose of this analysis, we will infer the predicate device's performance as the de facto "acceptance criteria" where specified.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (RapidVue hCG) |
|---|---|---|
| Sensitivity | 25 mIU/mL | 25 mIU/mL (verified as consistent with predicate) |
| Prozone Effect | No prozone effect observed | No prozone effect observed (verified as consistent with predicate) |
| Urinary pH Affect | Not affected by variations in urinary pH | Not affected by variations in urinary pH (verified) |
| Procedural Robustness | Consistent with predicate's robustness | Demonstrated robustness |
| Clinical Accuracy | Accuracy consistent with QuickVue One-Step hCG Urine test | Accuracy consistent with QuickVue One-Step hCG Urine test |
| Reproducibility by POL personnel | Performance consistent with predicate when used by POL personnel | Performance evaluated by physician office personnel |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "procured clinical urine samples" for the clinical sample testing but does not specify the sample size for this test set nor the country of origin of the data. It indicates these samples were used to verify accuracy against the predicate. The type of study (retrospective or prospective) for the clinical samples is also not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used, or their qualifications, to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not provide information on any adjudication method used for the test set. Given the nature of a rapid diagnostic test for a clear biomarker, adjudication by multiple readers might not be typically required unless there were ambiguous results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The "Physician Office Laboratory (POL) Reproducibility Study" involved physician office personnel, which implies multiple readers, but it focuses on reproducibility of the RapidVue hCG test itself, not a comparative effectiveness study with and without AI assistance (as this is a non-AI device). Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable and not reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is a rapid diagnostic immunoassay device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device's performance is inherently "standalone" in that it produces a result based on the chemical reaction, and then a human reads that result. The studies describe the device's inherent performance characteristics.
7. The Type of Ground Truth Used
The document implies the ground truth for the clinical sample testing would be the actual presence or absence of hCG in the urine samples, likely determined by a definitive laboratory method or clinical diagnosis of pregnancy. However, it does not explicitly state the specific method used to establish this definitive ground truth (e.g., expert consensus, pathology, outcome data, or a reference laboratory test). Given it's a quantitative measurement (hCG), a highly sensitive and specific lab assay is the most probable ground truth.
8. The Sample Size for the Training Set
This is a rapid diagnostic immunoassay, not a machine learning model that requires a "training set." Therefore, the concept of a "sample size for the training set" is not applicable. The device's performance is based on its chemical and biological design, not learned from data.
9. How the Ground Truth for the Training Set Was Established
As this is not a machine learning device, the concept of a "training set" and establishing "ground truth for the training set" is not applicable.
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510(k) SUMMARY
102175
ANG 25 2010
Submitted By:
Quidel Corporation 10165 McKellar Court San Diego, California 92121 Telephone: 858-552-1100 x1015 858-646-8045 Fax:
Submission Contact:
Michelle Bodien
August 23, 2010
RapidVue® hCG Test
hCG pregnancy test
JHI
Device Trade Name:
Common Name:
Date Prepared:
Predicate Device:
Intended Use:
Product Code
Device Classification/Name:
21 CFR 862.1155 / Human chorionic gonadotropin (hCG) Test System
The RapidVue hCG test is similar to other FDAcleared devices used for the qualitative detection of human chorionic gonadotropin (HCG) for the early detection of pregnancy.
QuickVue One-Step hCG Urine Test (K020799)
The Food and Drug Administration has classified test systems for the detection of pregnancy as Class II.
The RapidVue hCG test is an immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by health care professionals
Human chorionic gonadotropin is a hormone Physiologic Basis of the Test: produced by the placenta shortly after implantation. Since hCG is present in the urine of pregnant women, it is an excellent marker for confirming pregnancy.
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Device Description:
ﻟﺮﺳ
The RapidVue hCG test uses a monoclonal antibody specific to the beta subunit of hCG in a single-step technology to accurately detect hCG.
The Dipstick is dipped in urine. If hCG is present in the specimen at a level of 25 mlU/mL or greater, a pink-to-red Test (T) Line will appear along with a blue procedural Control (C) Line in the test result area. If hCG is present at lower levels, or not present in the specimen, only a blue procedural Control Line will appear in the test result area.
Device Comparison:
| Features | RapidVue hCG(Proposed) | QuickVue One-Step hCG Urine(K020799) |
|---|---|---|
| Intended Use | The RapidVue hCG test is animmunoassay intended for thequalitative detection of humanChorionic Gonadotropin (hCG) inurine for the early detection ofpregnancy. The test is intended foruse by health care professionals | The QuickVue One-Step hCG-Urine testis a one-step immunoassay for thequalitative detection of humanChorionic Gonadotropin (hCG) inurine for the early detection ofpregnancy. The test is intended foruse by health care professionals. |
| Analyte | Human Chorionic Gonadotropin | Human Chorionic Gonadotropin |
| Specimen Type | Urine | Urine |
| Format | Lateral-flow immunoassay (Dipstick) | Lateral-flow immunoassay (Cassette) |
| Total steps | 1 | 1 |
| Read Time | 3 minutes | 3 minutes |
| Sensitivity | 25 mIU/mL | 25 mIU/mL |
| Test Interpretation | Blue procedural control linePink-to-red test line | Blue procedural control linePink-to-red test line |
| Test stripcomponents | Test Line*Polyclonal goat anti-alpha hCGantibody is immobilized in the testzone on the nitrocellulose membraneIndicator*Monoclonal anti-hCG antibodycoupled to red-colored beads isincorporated into the Label Pad. | Test LinePolyclonal goat anti-alpha hCGantibody is immobilized in the testzone on the nitrocellulose membraneIndicatorMonoclonal antibody specific to thebeta subunit of hCG is incorporatedinto the Label Pad. |
| Control Line*An unrelated protein capable ofbinding the blue latex is spotted in thecontrol zone on the nitrocellulosemembrane. | Control LineAn unrelated protein capable ofbinding the blue latex is spotted in thecontrol zone on the nitrocellulosemembrane. |
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*Note: The monoclonal antibodies used for the Test Line and the Indicator in the RapidVue hCG test are identical to those used in the predicate QuickVue One-Step hCG Urine test. The components that generate the Control Line are also identical.
Summary of Performance Data:
Numerous analytical studies were undertaken to document the performance characteristics and the substantial equivalence of the RapidVue hCG test to the predicate device. These studies included the following:
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- Assay Sensitivity: to verify that the sensitivity of the RapidVue hCG test is consistent with QuickVue One-Step hCG Urine test.
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- Prozone Effect: to verify that no prozone effect is observed with the RapidVue hCG test as is consistent with QuickVue One-Step hCG Urine test.
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- Urinary pH: to verify that the RapidVue hCG test is not affected by variations in urinary pH.
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- Procedural Flex Testing: to demonstrate the robustness of the RapidVue hCG test and its test procedure.
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- Clinical Sample Testing: to verify that the accuracy of the RapidVue hCG test is consistent with QuickVue One-Step hCG Urine test using procured clinical urine samples.
- ్. Physician Office Laboratory (POL) Reproducibility Study: to evaluate the performance of the RapidVue hCG test by physician office personnel.
Conclusion:
The results of these studies demonstrate that the RapidVue hCG test is substantially equivalent with the predicate QuickVue One-Step hCG Urine test.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AUG 2 5 - 2010
Quidel Corporation c/o Ms. Michelle Bodien Senior Regulatory Affairs Specialist 10165 McKellar Court San Diego. CA 92121
Re: K102175
Trade Name: RapidVue hCG test Regulation Number: 21 CFR §862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system. Regulatory Class: Class II Product Codes: JHI Dated: July 30, 2010 Received: August 2, 2010
Dear Ms. Bodien:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
1102175 AN 2017 2
510(k) Number (if known): K102175
Device Name: RapidVue hCG test
Indications For Use:
The RapidVue hCG test is an immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by health care professionals.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Slan-
Office of In Vitro Digane Device Evaluation and Safety
510(K)
Page 1 of
§ 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.