(53 days)
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No
The description details a rapid immunoassay based on chemical reactions and visual interpretation of color lines, with no mention of AI or ML technologies.
No
The device is an immunoassay for detecting hCG, indicating pregnancy, which is a diagnostic function, not a therapeutic intervention.
Yes
The device is described as an "immunoassay intended for the semi-quantitative detection of human chorionic gonadotropin (hCG) in serum and the qualitative detection of hCG in urine for the early detection of pregnancy," which directly falls under the definition of a diagnostic device as it detects a physiological state (pregnancy) by measuring a specific biomarker (hCG).
No
The device description clearly outlines a physical immunoassay test kit involving a Test Cassette, Sample Well, and visual interpretation of color lines. This is a hardware-based in vitro diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the semi-quantitative detection of human chorionic gonadotropin (hCG) in serum and the qualitative detection of hCG in urine for the early detection of pregnancy." This involves testing biological samples (serum and urine) in vitro (outside the body) to provide information about a physiological state (pregnancy).
- Device Description: The description details a "rapid immunoassay" that analyzes serum or urine samples to detect the presence of hCG. This is a classic description of an in vitro diagnostic test.
- Performance Studies: The document describes studies using "serum and urine samples obtained from women presenting for pregnancy testing" and comparing the results to a "commercially distributed in vitro test." This further confirms its use in analyzing biological samples for diagnostic purposes.
- Reference Device: The mention of a "Reference Device" which is another "ImmunoConcentration™ Assay for hCG detection" reinforces that this device is intended for the same diagnostic purpose as other IVDs.
The core function of the device is to analyze biological samples in vitro to provide diagnostic information about a patient's condition (pregnancy), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The test is a rapid immunoassay for the semi-quantitative detection of hCG in serum and the qualitative detection of hCG in urine. This test is to be used for the early detection of pregnancy.
The QuickVue® Semi-Q hCG-Combo is a one-step immunoassay intended for the semi-quantitative detection of human chorionic gonadotropin (hCG) in serum and the qualitative detection of hCG in urine for the early detection of pregnancy. The QuickVue Semi-Q hCG-Combo is intended for use by health care professionals.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
The device, QuickVue Semi-Q hCG-Combo, is similar to other FDA-cleared devices used for the detection of human chorionic gonadotropin (hCG) in serum or urine. The test is used in the early detection 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.
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-purple Test Line will also appear. If hCG is not present, only the blue procedural Control Line will appear.
Serum results are interpreted by comparing the color development of the Test Line with a Reference Line. Serum results are reported as negative, positive less than 25 mIU/ml or positive greater than 25 mIU/mL. Urine results are interpreted as negative or positive.
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
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.
Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
The QuickVue Semi-Q hCG-Combo 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 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 serum and urine samples obtained from women presenting for pregnancy testing, a direct comparison of the test to the Hybritech® ICON® II HCG ImmunoConcentration™ Assay for 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.
These studies demonstrated the substantial equivalence of the QuickVue Semi-Q hCG-Combo to existing products already marketed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
An accuracy exceeding 99% was observed.
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.
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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.
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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).
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§ 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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS XI.
Product:
QuickVue® Semi-Q hCG-Combo
Manufacturer:
OUIDEL Corporation 10165 McKellar Court San Diego, CA 92121 U.S.A.
Device Classification:
The device, QuickVue Semi-Q hCG-Combo, is similar to other FDA-cleared devices used for the detection of human chorionic gonadotropin (hCG) in serum or urine. The test is used in the early detection 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 semi-quantitative detection of hCG in serum and the qualitative detection of hCG in 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 mIU/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.
1
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-purple Test Line will also appear. If hCG is not present, only the blue procedural Control Line will appear.
Serum results are interpreted by comparing the color development of the Test Line with a Reference Line. Serum results are reported as negative, positive less than 25 mIU/ml or positive greater than 25 mIU/mL. Urine results are interpreted as negative or positive.
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 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 serum and urine samples obtained from women presenting for pregnancy testing, a direct comparison of the test to the Hybritech® ICON® II HCG ImmunoConcentration™ Assay for 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 QuickVue Semi-Q hCG-Combo to existing products already marketed. They further demonstrated the suitability of the product for use by health care Such studies are a critical element in establishing the professionals. 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 and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top and bottom of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 9 1997
Robin Weiner . Vice President, Clinical Develop. & Reg. Affairs QUIDEL Corporation 10165 Mc Kellar Court San Dieqo, California 92121
K974052 Re : QuickVue® Semi-Q hCG-Combo Requlatory Class: II Product Code: JHI Dated: October 24, 1997 Received: October 27, 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, 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, qood 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 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 Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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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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 Sitman
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 _________________________________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device. Name:
OuickVue® Semi-Q hCG-Combo
Indications for Use:
The QuickVue® Semi-Q hCG-Combo is a one-step immunoassay intended for the semi-quantitative detection of human chorionic gonadotropin (hCG) in serum and the qualitative detection of hCG in urine for the early detection of pregnancy. The QuickVue Semi-Q hCG-Combo is intended for use by health care professionals.
UMichael for A. Montgomery
(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
Over-The Counter Use_
(Optional Format 1-2-96)