(50 days)
Empty
No
The device description and performance studies indicate a standard chromatographic immunoassay, with no mention of AI, ML, or image processing.
No
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is a diagnostic test used to detect pregnancy and does not provide any treatment.
Yes
The device is indicated as an "aid in the early detection 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 kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of human chorionic gonadotropin in urine or serum" and is "indicated for use as an aid in the early detection of pregnancy." This involves testing biological samples (urine and serum) in vitro (outside the body) to provide diagnostic information.
- Device Description: It's described as a "rapid qualitative chromatographic immunoassay," which is a common type of IVD test.
- Intended User / Care Setting: It's intended for use in a "clinical laboratory and/or physician's office," which are typical settings for performing IVD tests.
The core function of the device is to analyze a biological sample in vitro to provide information about a person's health status (pregnancy), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACON hCG Urine/Serum One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin in urine or serum.
The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid qualitative chromatographic immunoassay for the detection of human chorionic gonadotropin in urine or serum.
The ACON hCG Urine/Serum One Step Pregnancy Test is indicated for use as an aid in the early detection of pregnancy.
Product codes
JHI
Device Description
The ACON hCG Urine/Serum One Step 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
This device is intended to be used in the clinical laboratory and/or physician's office.
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)
Accuracy: A multi-center clinical evaluation was conducted which compared the results obtained in tests of 155 urine specimens using the ACON hCG Urine/Serum One Step Pregnancy Test and another commercially available membrane particle assay. The results of this study showed that both tests identified the same 76 negative and 79 positive results. The serum study included 57 specimens and both assays identified 38 negative and 19 positive results. The results of both urine and serum studies demonstrate a 100% overall agreement (for an Accuracy of ≥99%) of the ACON hCG Urine/Serum One Step Pregnancy Test in comparison to the other serum/urine test.
Sensitivity: Sensitivity was determined by spiking 20 clinical samples from normal, nonpregnant females with five different concentrations of hCG (0, 15, 20, 50, 100 mIU/ml). The detection limit claimed for the ACON hCG pregnancy test is 25 mIU/ml. All samples tested at concentrations of hCG as low as 15 mIU/ml produced positive results.
Specificity: Specificity studies were performed on specimens with high physiological concentrations of luteinizing hormone (LH), follicle stimulating hormone (FSH), and thyroid stimulating hormone (TSH). Negative results were obtained with all specimens tested with 300 mIU/ml hLH, 1000 mIU/ml hFSH, and 1000μJU/ml hTSH.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ≥ 99%
Sensitivity: 25 mIU/ml (claimed detection limit), positive results at 15 mIU/ml.
Specificity: No interferences observed with 300 mIU/ml hLH, 1000 mIU/ml hFSH, and 1000μJU/ml hTSH.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TestPack®Plus™ hCG Combo pregnancy test (K903219)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
APR 16 1998
K980736
6
ATTACHMENT A
Revised 510(k) Summary
ACON hCG Urine/Serum One Step Pregnancy Test Strip
1
10. 510(k) Summary
A. Name and Address of Submitter
Acon Laboratories, Inc. 115 Research Drive Bethlehem, PA 18015 Telephone: 609-397-8511 FAX: 609-397-8224 Contact Person: Patricia E. Bonness, Official Correspondent Date 510(k) Summary was prepared: April 3, 1998
B. Device Names
Proprietary Name: ACON® hCG Urine/Serum One Step Pregnancy Test
Common Name: Pregnancy Test
Classification Name: Human Chorionic Gonadotropin (hCG) Test System
C. Legally Marketed Device
The ACON® hCG Urine/Serum One Step Pregnancy Test has been determined to be substantially equivalent to the TestPack®Plus™ hCG Combo pregnancy test (K903219) currently in commercial distribution by Abbott.
D. Device Description
The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).
- E. Intended Use
The ACON hCG Urine/Serum One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin in urine or serum.
F. Comparison with Predicate Device
A summary comparison of the features of the ACON hCG and the TestPack®Plus™ hCG Combo pregnancy tests is provided in Table 1 on the following page.
2
Table 1
Feature Comparison of the ACON hCG and TestPack®Plus™ hCG Pregnancy Tests
| Parameter | ACON hCG | TestPack®Plus™ hCG |
|---|---|---|
| Intended Use | qualitative detection of | |
| hCG in urine and serum | qualitative detection of | |
| hCG in urine and serum | ||
| Indication for Use | early detection of | |
| pregnancy | early detection of pregnancy | |
| Specimen | urine and serum | urine and serum |
| Endpoint | colored lines | colored lines, plus & minus |
| Format | test strips | test strips within a device |
| Methodology | membrane particle assay | membrane particle assay |
| Storage | 15° to 30° C | 15° to 30° C |
| Test Time | 3 to 5 minutes | 3 to 5 minutes |
| Sensitivity | 25 mIU/ml | 20 mIU/ml |
| Accuracy | $≥$ 99% | $≥$ 99% |
| Specificity | No interferences | No interferences |
| Standardization | WHO Third International | |
| Standard | WHO Third International | |
| Standard |
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G. Performance Data
Accuracy
A multi-center clinical evaluation was conducted which compared the results obtained in tests of 155 urine specimens using the ACON hCG Urine/Serum One Step Pregnancy Test and another commercially available membrane particle assay . The results of this study showed that both tests identified the same 76 negative and 79 positive results. The serum study included 57 specimens and both assays identified 38 negative and 19 positive results. The results of both urine and serum studies demonstrate a 100% overall agreement (for an Accuracy of ≥99%) of the ACON hCG Urine/Serum One Step Pregnancy Test in comparison to the other serum/urine test.
Sensitivity
Sensitivity was determined by spiking 20 clinical samples from normal, nonpregnant females with five different concentrations of hCG (0, 15, 20, 50, 100 mIU/ml). The detection limit claimed for the ACON hCG pregnancy test is 25 mIU/ml. All samples tested at concentrations of hCG as low as 15 mIU/ml produced positive results.
Specificity
Specificity studies were performed on specimens with high physiological concentrations of luteinizing hormone (LH), follicle stimulating hormone (FSH), and thyroid stimulating hormone (TSH). Negative results were obtained with all specimens tested with 300 mIU/ml hLH, 1000 mIU/ml hFSH, and 1000μJU/ml hTSH.
Interfering Substances
No interference was observed in studies of specimens containing the following substances:
| Acetaminophen | 20 | mg/dl |
|---|---|---|
| Acetylsalicylic acid | 20 | mg/dl |
| Ascorbic acid | 20 | mg/dl |
| Atropine | 20 | mg/dl |
| Caffeine | 20 | mg/dl |
| Gentisic acid | 20 | mg/dl |
| Glucose | 2 | g/dl |
| Hemoglobin | 1 | mg/dl |
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 16 1998
Patricia E. Bonness . Official Correspondent Acon Laboratories, Inc. 115 Research Drive Bethlehem, Pennsylvania 18015
K980736 Re : ACON™ hCG Urine/Serum One Step Pregnancy Test Regulatory Class: II Product Code: JHI Dated: February 23, 1998 Received: February 25, 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 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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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 Drug 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 requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 leqally 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 regulation (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.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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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Page 1 of 1
510(k) Number (if known): K980736
Device Name: ACON™hCG Urine/Serum One Step Pregnancy Test
Indications For Use:
The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid qualitative chromatographic immunoassay for the detection of human chorionic gonadotropin in urine or serum.
The ACON hCG Urine/Serum One Step Pregnancy Test is indicated for use as an aid in the early detection of pregnancy. This device is intended to be used in the clinical laboratory and/or physician's office.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
510(k) Number _
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices