(50 days)
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.
The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device K903219) | Reported Device Performance (ACON hCG Urine/Serum One Step Pregnancy Test) |
|---|---|---|
| Sensitivity | 20 mIU/ml | 15 mIU/ml (All samples tested at 15 mIU/ml produced positive results) |
| Accuracy | ≥ 99% | 100% overall agreement (indicating ≥ 99% accuracy) |
| Specificity | No interferences | No interferences with high concentrations of LH, FSH, TSH, and common substances |
2. Sample Size Used for the Test Set and Data Provenance
- Urine Test Set:
- Sample Size: 155 urine specimens.
- Data Provenance: Not explicitly stated, but it was a "multi-center clinical evaluation," suggesting prospective collection from various clinical sites. No country of origin is mentioned.
- Serum Test Set:
- Sample Size: 57 serum specimens.
- Data Provenance: Not explicitly stated, but part of the same "multi-center clinical evaluation," suggesting prospective collection from various clinical sites. No country of origin is mentioned.
- Sensitivity Test Set:
- Sample Size: 20 clinical samples (from normal, non-pregnant females), spiked with hCG at various concentrations (0, 15, 20, 50, 100 mIU/ml).
- Data Provenance: Clinical samples from normal, non-pregnant females. The spiking indicates laboratory-controlled conditions.
- Specificity Test Set:
- Sample Size: Not explicitly stated for each hormone (LH, FSH, TSH) or for interfering substances. The wording "all specimens tested" suggests multiple samples for each.
- Data Provenance: Specimens with high physiological concentrations of relevant hormones and specimens spiked with potentially interfering substances.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in-vitro diagnostic test for qualitative detection of hCG. The "ground truth" for the accuracy study was established by comparison to another commercially available membrane particle assay, implying the reference device's results were considered the ground truth. For sensitivity, the ground truth was the known concentration of spiked hCG. For specificity, the ground truth was the known presence or absence of specific interfering substances. No human expert interpretation was involved in establishing the ground truth for this type of test.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth was established either by comparison to a predicate device's results or by known spiked concentrations/substances. There was no human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in-vitro diagnostic device that provides an objective visual result (colored lines); it is not an AI-powered image analysis or diagnostic aid that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations of the ACON hCG Urine/Serum One Step Pregnancy Test. The device itself performs the detection; there is no human interpretation of an algorithm's output.
7. The Type of Ground Truth Used
- Accuracy: Another "commercially available membrane particle assay" (likely the predicate device or a similar validated test). The results of this comparator assay served as the ground truth.
- Sensitivity: Known, precisely spiked concentrations of hCG in clinical samples.
- Specificity: Known concentrations of other hormones (LH, FSH, TSH) and common interfering substances.
8. The Sample Size for the Training Set
Not applicable. This is a rapid immunoassay test, not a machine learning or AI-based device that requires a "training set." Its principles of operation rely on biochemical reactions, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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APR 16 1998
K980736
6
ATTACHMENT A
Revised 510(k) Summary
ACON hCG Urine/Serum One Step Pregnancy Test Strip
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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.
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Table 1
Feature Comparison of the ACON hCG and TestPack®Plus™ hCG Pregnancy Tests
| Parameter | ACON hCG | TestPack®Plus™ hCG |
|---|---|---|
| Intended Use | qualitative detection ofhCG in urine and serum | qualitative detection ofhCG in urine and serum |
| Indication for Use | early detection ofpregnancy | 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 InternationalStandard | WHO Third InternationalStandard |
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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 |
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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
§ 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.