(66 days)
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No
The description details a rapid immunoassay based on chemical reactions and visual interpretation of lines, with no mention of computational analysis, algorithms, or learning processes.
No
The device is described as an immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) for the early detection of pregnancy, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is an immunoassay designed for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine, for the early detection of pregnancy. This process provides information about a patient's health status (pregnancy) and is used to diagnose a physiological condition.
No
The device description clearly describes a physical immunoassay test cassette with a sample well and result window, indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy." This involves testing a sample taken from the human body (serum or urine) in vitro (outside the body) to provide information about a physiological state (pregnancy).
- Device Description: The description details a "rapid immunoassay for the qualitative detection of hCG in serum or urine." Immunoassays are a common type of in vitro diagnostic test.
- Performance Studies: The summary of performance studies mentions "other commercially distributed in vitro tests" and a "direct comparison of the test to a commercially available qualitative hCG test." This further reinforces its classification as an in vitro diagnostic.
The core function of the device is to analyze a biological sample in vitro to diagnose or provide information about a medical condition or physiological state, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
The test is a rapid immunoassay for the qualitative detection of hCG in serum or urine. This test is to be used for the early detection of pregnancy.
The QuickVue One-Step hCG-Combo is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test is intended for use by health care professionals.
Product codes
JHI
Device Description
Serum or urine is added to the Sample Well on the Test Cassette. Shortly after addition of the sample, a blue procedural Control Line will appear in the Result Window. If hCG is present in the sample, a pink-to-red Test Line will also appear. If hCG is not present, only the blue procedural Control Line will appear.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Physicians' Office studies were conducted to demonstrate that physician office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly.
The test is intended for use by health care professionals.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to other commercially available products for the qualitative detection of hCG in serum or urine. These 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 samples obtained from women presenting for pregnancy testing, a direct comparison of the test to a commercially available qualitative hCG test was conducted. An accuracy exceeding 99% was observed.
- Physicians' Office studies were conducted to demonstrate that physician office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
An accuracy exceeding 99% was observed.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 1 7 2002
KO20801
SUMMARY OF SAFETY AND EFFECTIVENESS XI.
Product: QuickVue® One-Step hCG-Combo
Manufacturer:
Quidel Corporation 10165 McKellar Court San Diego, California 92121 U.S.A.
Device Classification:
Dovice, QuickVue One-Step hCG-Combo, is similar to other FDA-cleared devices used for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine. The test is the qualitative ustomor of pregnancy and is intended to measure hCG, a placental hormone, in serum, plasma or urine (21 CFR 862.1155). The FDA has proposed that hCG test systems be classified as Class II.
Intended Use:
The test is a rapid immunoassay for the qualitative detection of hCG in serum or urine. This 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 mlU/mL. Serum hCG is rapidly cleared in the urine and the concentration of hCG in serum is approximately equal to the concentration in urine. HCG is an excellent indicator of pregnancy early in the gestational period.
Principle of the Test:
Serum or urine is added to the Sample Well on the Test Cassette. Shortly after addition of the sample, a blue procedural Control Line will appear in the Result Window. If hCG is present in the sample, a pink-to-red Test Line will also appear. If hCG is not present, only the blue procedural Control Line will appear.
1
Safety and Effectiveness:
Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to other commercially available products for the qualitative detection of hCG in serum or urine. These studies included the following:
- The test was shown to be similar to other commercially distributed in vitro tests in terms of 1. 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 4. performance.
-
- JUsing samples obtained from women presenting for pregnancy testing, a direct comparison of the test to a commercially available qualitative hCG test was conducted. An accuracy exceeding 99% was observed.
-
- Physicians' Office studies were conducted to demonstrate that physician office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly.
Conclusion:
These studies demonstrated the substantial equivalence of the QuickVue One-Step hCG-Combo test to currently marketed devices which have been reviewed and cleared through the 510(k) notification process. 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 health, human services, and the U.S. population. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 7 2002
Ms. Jennifer S. Hankard Regulatory Affairs Manager Quidel Corporation 10165 McKellar Court San Diego, CA 92121
Re: K020801
Trade/Device Name: QuickVue® One-Step hCG-Combo Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: March 11, 2002 Received: March 12, 2002
Dear Ms. Hankard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 regulation (21 CFR Part 801 and 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/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
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INDICATIONS FOR USE (Separate Page): XIII.
| Page | 1 of 1 |
|---|---|
| 510(k) Number (if known): | K020801 |
Device Name:
QuickVue® One-Step hCG-Combo
Indications for Use:
The QuickVue One-Step hCG-Combo is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test is intended for use by health care professionals.
Dlen Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Numbe
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The Counter Use_
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