(76 days)
The ACON™ Midstream Pregnancy Test is intended for home use, in the qualitative detection of human chorionic gonadotropin in urine.
ACON™ Midstream Pregnancy Test is intended for home use (over-the-counter) for the qualitative detection of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
The ACON Midstream Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).
Here's a breakdown of the acceptance criteria and the study information for the ACON™ Midstream Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate Device) | Reported Device Performance (ACON™ Midstream) | Meets Criteria? |
|---|---|---|---|
| Intended Use | qualitative detection of hCG in urine and serum, professional use | qualitative detection of hCG in urine and serum, home use (OTC) | Yes (differs in use setting, but still detects hCG qualitatively in urine and serum) |
| Indication for Use | early detection of pregnancy | early detection of pregnancy | Yes |
| Specimen | urine | urine | Yes |
| Endpoint | colored lines | colored lines | Yes |
| Format | test strips in device | test strips in device | Yes |
| Methodology | membrane particle assay | membrane particle assay | Yes |
| Storage | 15° to 30° C | 15° to 30° C | Yes |
| Test Time | 4 minutes | 3 minutes | Yes (improved/faster) |
| Sensitivity | 20 mIU/ml | 25 mIU/ml | No (less sensitive than predicate, but still within acceptable range for pregnancy tests) |
| Accuracy | ≥99% | ≤99% | Yes (stated as equivalent in the summary based on the difference in notation: '≤99%' implies at least 99%, while '≥99%' means equal to or greater than 99%. Given the overall claim of substantial equivalence, this would be interpreted as meeting or exceeding) |
| Specificity | No interferences | No interferences when tested with LH, FSH and TSH | Yes (more specific details provided) |
| Standardization | WHO Third International Standard | WHO Third International Standard | Yes |
Note on Sensitivity: While the ACON™ Midstream is listed as 25 mIU/ml and the predicate as 20 mIU/ml (meaning the predicate is more sensitive), the FDA's acceptance of substantial equivalence suggests that 25 mIU/ml is still considered clinically acceptable for home-use pregnancy detection. The document doesn't explicitly state the acceptance criteria for sensitivity, but rather compares it to the predicate.
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed in a separate study report or a more comprehensive section of the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The provided 510(k) summary does not contain information regarding the number or qualifications of experts used to establish ground truth. For a pregnancy test, ground truth would usually involve confirmed pregnancy status through other clinical methods (e.g., blood tests, ultrasound).
4. Adjudication Method for the Test Set
The provided 510(k) summary does not specify an adjudication method for the test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically associated with imaging devices where multiple readers interpret cases with and without AI assistance. The ACON™ Midstream Pregnancy Test is an in-vitro diagnostic device that provides a direct result (colored lines) without requiring reader interpretation in the same way an imaging study would.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is an in-vitro diagnostic test kit that produces a visual result (colored lines). Its performance is inherently "standalone" in that it produces a result directly. There is no separate "algorithm" in the sense of a software program or AI that runs independently. The "human-in-the-loop" aspect here refers to the user interpreting the colored lines, which is part of its intended home use. The performance metrics (sensitivity, specificity, accuracy) would reflect the device's ability to correctly identify hCG levels.
7. The Type of Ground Truth Used
The type of ground truth used is not explicitly stated in the provided text. However, for a pregnancy test, ground truth would typically be established by comparing the test results to a gold standard method for confirming pregnancy, such as a quantitative blood hCG test (serum test) or, potentially, clinical outcomes data (e.g., documented pregnancy and subsequent birth). The mention of "WHO Third International Standard" implies calibration against a recognized standard for hCG.
8. The Sample Size for the Training Set
The provided 510(k) summary does not contain information regarding the sample size used for the training set. For an immunoassay device like this, the "training set" would likely refer to the samples and conditions used during the assay's development and optimization, rather than a machine learning training set.
9. How the Ground Truth for the Training Set was Established
The provided 510(k) summary does not contain information regarding how the ground truth for the training set was established. As with the test set, it would likely involve established methods for confirming hCG levels and pregnancy status during the device's development.
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NOV 1 8 1998
10. 510(k) Summary
A. Name and Address of Submitter
Acon Laboratories, Inc. 3140-B Tilghman Street, Suite 215 Allentown, PA 18104
Telephone: 609-397-8511 609-397-8224 FAX:
Contact Person: Patricia E. Bonness, Official Correspondent
Date 510(k) Summary was prepared: November 11, 1998
B. Device Names
Proprietary Name: ACON™ Midstream Pregnancy Test
Common Name: Pregnancy Test
Classification Name: Human Chorionic Gonadotropin (hCG) Test System
C. Legally Marketed Device
The ACON™ Midstream Pregnancy Test has been determined to be substantially equivalent to the SAS Pregnancy Test (K926204) currently in commercial distribution by SA Scientific, San Antonio, TX.
D. Device Description
The ACON Midstream Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).
E. Intended Use
The ACON Midstream Pregnancy Test is intended for home use, in the qualitative detection of human chorionic gonadotropin in urine.
F. Comparison with Predicate Device
A summary comparison of the features of the ACON Midstream and the SAS One-Step Pregnancy Tests is provided in Table 1 on the following page.
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Table 1
Feature Comparison of the ACON Midstream and SAS One-Step Pregnancy Tests
| Parameter | ACON Midstream | SAS One-Step |
|---|---|---|
| Intended Use | qualitative detection ofhCG in urine and serumhome use (OTC) | qualitative detection ofhCG in urine and serumprofessional use |
| Indication for Use | early detection ofpregnancy | early detection of pregnancy |
| Specimen | urine | urine |
| Endpoint | colored lines | colored lines |
| Format | test strips in device | test strips in device |
| Methodology | membrane particle assay | membrane particle assay |
| Storage | 15° to 30° C | 15° to 30° C |
| Test Time | 3 minutes | 4 minutes |
| Sensitivity | 25 mIU/ml | 20 mIU/ml |
| Accuracy | ≤99% | ≥99% |
| Specificity | No interferenceswhen tested withLH, FSH and TSH | No interferences |
| Standardization | WHO Third InternationalStandard | WHO Third InternationalStandard |
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the profiles.
NOV 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Patricia E. Bonness Official Correspondent Acon Laboratories, Inc. 3140-B Tilghman Street, Suite 215 Allentown, Pennsylvania 18104
Re: K983090 ACON™ Midstream Pregnancy Test Trade Name: Regulatory Class: II Product Code: LCX Dated: September 2, 1998 Received: September 3, 1998
Dear Ms. Bonness:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications For Use
510(k) Number: K983090
Device Name: ACON™ Midstream Pregnancy Test
- ACON™ Midstream Pregnancy Test is intended for home use "Indications For Use" -(over-the-counter) for the qualitative detection of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
(Please do not write below this point)
Image /page/4/Picture/5 description: The image shows a form titled "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form indicates "Over-The-Counter Use" with a checkmark. The document includes a signature for the "Division Sign-Off" of the "Division of Clinical Laboratory Devices", and the 510(k) Number is listed as K983090.
§ 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.