(62 days)
Accunate Home Pregnancy Test is an over-the-counter (OTC) one-step qualitative test for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
ACCUNATE™ONE-STEP, ACCUNATE™ONE-STEP CASSETTE and ACCUNATE-CHOICE™ are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine or in urine and serum for the early detection of pregnancy.
Here's a breakdown of the acceptance criteria and study information for the ACCUNATE series of pregnancy tests, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" as a separate, defined section with numerical targets. Instead, the studies aim to demonstrate "substantial equivalence" of the new devices to existing predicate devices. The performance metrics are relative to these predicates and directly inform the claim of equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|---|
| Agreement with Predicate (ACCUNATE™ONE-STEP & ACCUNATE™ONE-STEP CASSETTE vs. Abbott Test Pack Plus™) | 100% agreement with predicate | 100% agreement (63 positives, 68 negatives) | Demonstrates comparable qualitative detection of hCG in urine. |
| Agreement with Predicate (ACCUNATE-CHOICE™ vs. Quidel's Quick-Vue®) | 100% agreement with predicate | 100% agreement (59 positives, 60 negatives) | Demonstrates comparable qualitative detection of hCG in urine or serum. |
| Sensitivity (Detection Limit) | 25 mIU/ml or better (implied by predicate devices' capabilities) | 25 mIU/ml | Demonstrated by detecting hCG at 25 mIU/ml and above, but not at 5 mIU/ml. |
| Home User vs. Professional User Agreement (ACCUNATE™ HOME PREGNANCY TEST vs. ACCUNATE™ ONE-STEP CASSETTE) | High agreement, demonstrating user-friendliness and reliable results in a home setting (no explicit percentage given, but 98% is achieved). | 98% agreement (47 home positives vs. 46 lab, 59 home negatives vs. 61 lab, 1 home invalid vs. 0 lab) | This study assesses the usability and accuracy of the home test when used by laypersons compared to trained professionals. |
2. Sample Size Used for the Test Set and Data Provenance
- ACCUNATE™ONE-STEP & ACCUNATE™ONE-STEP CASSETTE:
- Sample Size: 131 urine specimens.
- Data Provenance: Prospective. Specimens were from "patients seeking confirmation of pregnancy" and tested simultaneously with the devices and predicate. The study was conducted at "three clinic sites," implying a likely domestic (USA) origin given the context of a US regulatory submission.
- ACCUNATE-CHOICE™:
- Sample Size: 119 serum specimens.
- Data Provenance: Prospective. Specimens from "normal male and non pregnant females" were tested simultaneously. The study details are similar to the above, suggesting a domestic (USA) origin.
- Sensitivity Testing:
- Sample Size: 20 urine specimens and 20 serum specimens for each hCG concentration (0, 5, 25, 50, 100 mIU/ml). This means a total of 100 urine samples and 100 serum samples were tested across the concentrations.
- Data Provenance: Controlled laboratory spike study. No geographic origin specified, but likely conducted internally or at a contract lab.
- Home User Study (ACCUNATE™ HOME PREGNANCY TEST):
- Sample Size: 107 participants/samples.
- Data Provenance: Prospective. Conducted at "three clinic sites," with participants being home users testing their own urine. Likely domestic (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The studies rely on the performance of predicate devices (Abbott Test Pack Plus™ and Quidel's Quick-Vue®) as the de facto "ground truth" for comparative effectiveness. These devices are established, legally marketed pregnancy tests.
For the home user study, the "ground truth" was established by laboratory professionals using the ACCUNATE™ ONE-STEP CASSETTE. The qualifications of these professionals are not explicitly stated (e.g., "radiologist with 10 years of experience"), but it is implied they are trained and experienced in performing such clinical laboratory tests. There's no mention of a specific number of experts beyond "the laboratory."
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The comparisons are based on direct agreement with the predicate devices' results or the laboratory results in the home user study. Discrepancies, especially in the home user study, are noted (e.g., one home invalid result not found by the lab), but no formal adjudication process for such discrepancies is detailed in the summary. For the comparative studies, 100% agreement means no discrepancies requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No formal MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is measured. These studies are focused on the standalone performance of the devices and their agreement with predicate devices or a professional laboratory reference.
6. Standalone (Algorithm Only) Performance
Yes, standalone performance was done. The entire set of studies focuses on the device's performance as a standalone test, without human interpretation influencing the primary result (though humans obviously perform the test and read the result). The "100% agreement" and "25 mIU/ml sensitivity" directly reflect the standalone performance of the ACCUNATE devices.
7. Type of Ground Truth Used
- Comparative Studies (with Abbott Test Pack Plus™ and Quidel's Quick-Vue®): Predicate device results. This is a common approach for demonstrating substantial equivalence for new diagnostic devices. The assumption is that the predicate device's results are accurate and serve as the clinical reference.
- Sensitivity Study: Laboratory-prepared spiked samples with known concentrations of hCG. This is a controlled, objective ground truth for measuring the detection limit.
- Home User Study: Laboratory professional results using a comparable ACCUNATE™ device (ACCUNATE™ ONE-STEP CASSETTE). This serves as the expert reference for evaluating home user accuracy.
8. Sample Size for the Training Set
The document does not mention any "training set." These devices (lateral flow immunoassays) are not AI/algorithm-based devices that typically require training data. Their performance is inherent to their chemical and physical design.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this question is not applicable.
{0}------------------------------------------------
| Cenogenics Corporation | |
|---|---|
| 100 Route 520 • Drawer 308Morganville, New Jersey 07751 | Telephone (732) 536-6457 • (800) 747-9457Fax (732) 972-8527 • e-mail: inquiry@cenogenics.com |
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Proprietary name: | ACCUNATE™-ONE STEPACCUNATE™ONE STEP CASSETTEACCUNATE-CHOICE™ACCUNATE™ HOME PREGNANCY TEST |
|---|---|
| Common name: | Pregnancy test for urine or serum |
| Classification: | 21CFR862.1155, Class II |
| Classification number: | 75DHA |
| Establishment: | Cenogenics Corporation100 Route 520Morganville, New Jersey 07751 |
| Contact: | Nitza KatzVice President |
K030533
APR 17 2003
ACCUNATE™ONE-STEP, ACCUNATE™ONE-STEP CASSETTE and ACCUNATE-CHOICE™ are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine or in urine and serum for the early detection of pregnancy.
Comparison studies were conducted at three clinic sites. Urine specimens from patients seeking confirmation of pregnancy were tested simultaneously with ACCUNATE™ONE-STEP and ACCUNATE™ONE-STEP CASSETTE and the Abbott Test Pack Plus™. The Test Pack Plus™ is a similar colloidal gold test for the qualitative determination of hCG in urine for the early detection of pregnancy. A total of 131 specimens were tested. Test results showed 100% agreement with the Abbott Test Pack Plus™. TABLE 1A demonstrates distribution of positive and negative specimens.
- Comparison of ACCUNATE™-ONE STEP and ACCUNATE™-ONE STEP 1A: TABLE CASSETTE with the Abbott Test Pack Plus™
| ACCUNATE™-ONE STEP | ACCUNATE™-ONE STEPCASSETTE | ABBOTT TEST PACKPLUS™ | |
|---|---|---|---|
| NO. OF POSITIVES | 63 | 63 | 63 |
| NO. OF NEGATIVES | 68 | 68 | 68 |
{1}------------------------------------------------
Serum specimens from normal male and non pregnant females were tested simultaneously with ACCUNATE-CHOICE™ and Quidel's Quick-Vue®. The Quick-Vue is a similar device for the qualitative determination of hCG in urine or serum for the early detection of pregnancy. A total of 119 samples were tested. Test results showed 100% agreement with the Quick-Vue . Table 1B shows the distribution of positive and negative samples.
TABLE 1B: Comparison of ACCUNATE-CHOICE™ with QUICK-VUE®
| ACCUNATE-CHOICE™ | QUICK-VUE® | |
|---|---|---|
| NO. OF POSITIVES | 59 | 59 |
| NO. OF NEGATIVES | 60 | 60 |
Twenty urine specimens and twenty serum specimens were spiked with hCG at concentrations of 5, 25, 50 and 100m IU/ml. Each urine specimen was tested at the hCG concentrations stated and at 0mlU/ml with ACCUNATE™ ONE-STEP, ACCUNATE™ ONE-STEP CASSETTES and ACCUNATE-CHOICE™. The serum specimens were tested with ACCUNATE-CHOICE™. Testing data demonstrates the sensitivity to be 25mlU/ml. Test results are shown in TABLE 2.
TABLE 2: Sensitivity Test Results
| hCG CONCENTRATION | |||||
|---|---|---|---|---|---|
| 0IU/ml | 5mlU/ml | 25mlU/ml | 50mlU/ml | 100mlU/ml | |
| NO. OF SAMPLES TESTED | 20 | 20 | 20 | 20 | 20 |
| POSITIVE RESULTS | 0 | 0 | 20 | 20 | 20 |
| NEGATIVE RESULTS | 20 | 20 | 0 | 0 | 0 |
A study comparing the test results obtained by the home user with the ACCUNATE™ HOME PREGNANCY TEST to the test results obtained by the professional user with the ACCUNATE™ ONE-STEP CASSETTE was performed at three clinic sites. A total of 107 participants were included in this study. The agreement between the home user and the laboratory professional test results was 98%. Table 3 shows the comparison test result data.
- TABLE 3: Comparison of the test results reported by the Home User with the test results reported by the laboratory.
| Home User | Laboratory | |
|---|---|---|
| Number of Positives | 47 | 46 |
| Number of Negatives | 59 | 61 |
| Number of Invalid | 1 | 0 |
| TOTAL | 107 | 107 |
{2}------------------------------------------------
The above testing data demonstrates that ACCUNATE™-ONE STEP and the ACCUNATE™-ONE STEP CASSETTE are substantially equivalent to the Abbott Test Pack Plus™ and that the ACCUNATE-CHOICE™ is substantially equivalent to Quidel's Quick-Vue°. The test results obtained by the home user with the ACCUNATE™ HOME PREGNANCY TEST is substantially equivalent to the test results obtained by the laboratory professional with the ACCUNATE™ ONE-STEP CASSETTE. The devices are equivalent in test principle, sensitivity and performance.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 7 2003
Ms. Nitza Katz Vice President Cenogenics. Corporation 100 Route 520 Morganville, NJ 07751
K030533 Trade/Device Name: Accunate Home Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: February 10, 2003 Received: February 14, 2003
Dear Ms. Katz:
Re:
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. Iisting 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{4}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page
of
510(k) Number (if known): K030533
Device Name: ACCUNATE HOME PREGNANCY TEST
Indications For Use:
Accunate Home Pregnancy Test is an over-the-counter (OTC) one-step qualitative test for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C Benson/P Jean Cooper
(Division Sign-Off) Division of Clinical Laborator 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter
(Optional Format 1-2-96)
§ 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.