(76 days)
Not Found
No
The device description and the lack of mentions of AI, DNN, or ML, along with the simple immunoassay technology, indicate no AI/ML is used.
No
The device aids in the determination of pregnancy, which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate any condition.
Yes
The device is described as aiding "in the determination of pregnancy," which is a diagnostic purpose to identify a physiological state.
No
The device description explicitly states it is a "rapid chromatographic immunoassay (membrane particle assay)," which is a physical test strip, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in the qualitative detection of human chorionic gonadotropin in urine." This involves testing a sample (urine) taken from the body to provide information about a physiological state (pregnancy).
- Device Description: It's described as a "rapid chromatographic immunoassay (membrane particle assay)." Immunoassays are a common type of IVD test.
- Detection of a Biomarker: It detects hCG (human Chorionic Gonadotropin), which is a biomarker found in urine that indicates pregnancy.
- Qualitative Detection: It provides a qualitative result (positive or negative for pregnancy), which is a typical output for many IVD tests.
The fact that it's intended for home use (OTC) and doesn't involve image processing, AI, or specific anatomical sites doesn't preclude it from being an IVD. IVDs encompass a wide range of tests, from complex laboratory analyzers to simple home-use kits.
N/A
Intended Use / Indications for Use
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.
Product codes
LCX
Device Description
The ACON Midstream Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use (OTC)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25 mIU/ml
Accuracy: ≤99%
Specificity: No interferences when tested with LH, FSH and TSH
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
Table 1
Feature Comparison of the ACON Midstream and SAS One-Step Pregnancy Tests
| Parameter | ACON Midstream | SAS One-Step |
|---|---|---|
| Intended Use | qualitative detection of | |
| hCG in urine and serum | ||
| home use (OTC) | qualitative detection of | |
| hCG in urine and serum | ||
| professional use | ||
| Indication for Use | early detection of | |
| pregnancy | 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 interferences | |
| when tested with | ||
| LH, FSH and TSH | No interferences | |
| Standardization | WHO Third International | |
| Standard | WHO Third International | |
| Standard |
2
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.
3
Page 2
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
4
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.