(37 days)
Not Found
Not Found
No
The device description and performance studies describe a standard lateral-flow immunoassay that relies on chemical reactions and visual interpretation, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic test for the early detection of pregnancy, not a device used for treating or modifying a disease state.
Yes
The device qualitatively detects human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy, which is a diagnostic purpose.
No
The device description clearly describes a lateral-flow immunoassay, which is a physical test strip with antibodies and reagents. This is a hardware component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy." This is a diagnostic purpose performed on a biological sample (urine).
- Device Description: The description details a "rapid immunoassay for the qualitative detection of hCG in urine." Immunoassays are a common type of in vitro diagnostic test.
- Performance Studies: The document describes studies comparing the device to "other commercially distributed in vitro tests" and "other FDA-cleared devices for qualitative hCG detection." This further confirms its classification as an IVD.
The term "In Vitro Diagnostic" refers to medical devices that are used to examine specimens, such as blood, urine, or tissue, from the human body to help diagnose diseases or conditions. This description perfectly aligns with the QuickVue One-Step hCG-Urine test.
N/A
Intended Use / Indications for Use
The test is a rapid immunoassay for the qualitative detection of hCG in urine. This test is to be used for the early detection of pregnancy.
The QuickVue® One-Step hCG-Urine is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The QuickVue One-Step hCG-Urine is intended for use by health care professionals.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
Not Found
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
health care professionals.
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)
- The test was shown to be similar to other commercially distributed in vitro tests in terms of features and intended use.
- The test was shown to have excellent intra- and inter-assay precision.
- Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
- Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
- Using urine samples obtained from women presenting for pregnancy testing, a direct comparison of the test to other FDA-cleared devices for qualitative hCG detection was conducted. An accuracy exceeding 99% was observed.
- Physician's Office Laboratory studies were conducted to show that doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed 100% with the expected results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
accuracy exceeding 99%
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.
Not Found
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
0(k) SUMMARY OF SAFETY AND EFFECTIVENESS
K 472742
Product: uickVue® One-Step hCG-Urine
AUG 2 9 1997
Manufacturer: OUIDEL Corporation 10165 McKellar Court San Diego, CA 92121 U.S.A.
ce Classification:
evice, OuickVue One-Step hCG-Urine, is similar to other FDA-cleared s used for the qualitative detection of human chorionic gonadotropin in urine. The test is used in the early detection of pregnancy and is d to measure hCG, a placental hormone, in urine (21 CFR 862.1155). DA has proposed that hCG test systems be classified as Class II.
ended Use:
e test is a rapid immunoassay for the qualitative detection of hCG in urine. his test is to be used for the early detection of pregnancy.
Physiologic Basis for the Assay:
Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the trophoblastic cells of the developing placenta as early as 7 to 8 days after ovulation. This hormone stimulates the production of progesterone and estradiol which are required to sustain pregnancy. In normal pregnancy, serum levels of hCG continue to rise during the first trimester to levels as high as 100,000 mIU/mL. Serum hCG is rapidly cleared in the urine and the corcentration of hCG in serum is approximately equal to the concentration in urine. HCG is an excellent indicator of pregnancy early in the gestational period.
1
ciple of the Test:
est, a lateral-flow immunoassay, employs monoclonal and polyclonal bodies. Shortly after addition of the urine sample, a blue procedural ol Line will appear. If hCG is present in the sample, a pink-to-purple Line will also appear. The result is read at three minutes. If no blue cedural Control Line develops, the result is considered invalid.
Safety and Effectiveness:
Jumerous studies were undertaken to document the performance haracteristics and the substantial equivalence of the test to other ommercially available products for the qualitative detection of hCG in urine. hese studies included the following:
- · The test was shown to be similar to other commercially distributed in vitro tests in terms of features and intended use.
- · The test was shown to have excellent intra- and inter-assay precision.
- · Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
- · Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance.
- · Using urine samples obtained from women presenting for pregnancy testing, a direct comparison of the test to other FDA-cleared devices for qualitative hCG detection was conducted. An accuracy exceeding 99% was observed.
- · Physician's Office Laboratory studies were conducted to show that doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed 100% with the expected results.
Conclusion:
These studies demonstrated the substantial equivalence of the test to existing products already marketed. They further demonstrated the suitability of the product for use by health care professionals. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Aarrinistration 2098 Gaither Road Rockville MD 20850
AUG 2 9 1097
Robin Weiner Vice President, Clinical Develop. & Reg. Affairs QUIDEL Corporation 10165 Mc Kellar Court San Diego, California 92121
K972742 Re: QuickVue® One-Step hCG-Urine Requlatory Class: II Product Code: JHI July 22, 1997 Dated: Received: July 23, 1997
Dear Ms. Weiner:
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, Druq, 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. 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 requlation (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 Reqister. 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.
3
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 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 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 Sutman
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
| Page 1 of 1 | ||
|---|---|---|
| -- | -- | ----------------------------------------------------------------------- |
| 510(k) Number (if known): | K972742 |
|---|---|
| Device Name: | QuickVue® One-Step hCG-Urine |
Indications for Use:
The QuickVue® One-Step hCG-Urine is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The QuickVue One-Step hCG-Urine is intended for use by health care professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972742 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
ಷ
i