(48 days)
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No
The summary describes a standard immunoassay for hCG detection, which relies on chemical reactions and visual interpretation, not AI/ML algorithms. There is no mention of AI, ML, or related concepts in the document.
No
The device is 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
The device is intended for the "qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy." This process of detecting a biological marker to identify a condition (pregnancy) is inherently diagnostic.
No
The device description clearly indicates it is an immunoassay for detecting hCG in serum or urine, which is a laboratory test involving physical reagents and samples, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy." This involves testing samples taken from the human body in vitro (outside the body).
- Device Description: The description mentions it's used to "measure hCG, a placental hormone, in serum, plasma or urine (21 CFR 862.1155)." This regulation (21 CFR 862.1155) specifically pertains to "Human chorionic gonadotropin (hCG) test system," which is a type of IVD.
- Performance Studies: The performance studies describe testing "samples obtained from women presenting for pregnancy testing" and comparing the results to another "FDA-cleared device for qualitative hCG detection." This further confirms its use in analyzing biological samples.
The entire description aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The test is a rapid and sensitive immunoassay for the qualitative detection of hCG in serum or urine. This test is intended for use as an aid in the diagnosis of early pregnancy.
The CARDS® Q.S.® hCG Serum/Urine (also sold under the brand name Concise® Performance Plus™ 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.
Product codes
JHI
Device Description
The device, CARDS Q.S. hCG Serum/Urine (also sold under the brand name Concise Performance Plus 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 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).
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
"The test is intended for use by health care professionals."
"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."
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)
- 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 another FDA-cleared device 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 greater than 100% with the expected results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy exceeding 99%
Predicate Device(s)
Not Found (The document states "similar to other FDA-cleared devices" and "substantial equivalence of the test to existing products already marketed" but does not list specific K/DEN numbers for predicate devices.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
2973858
SUMMARY OF SAFETY AND EFFECTIVENESS XI.
NOV 26 1997
Product:
CARDS® Q.S.® hCG Serum / Urine; or Concise® Performance Plus™ hCG-Combo
Distributor:
Pacific Biotech, Incorporated a subsidiary of QUIDEL Corporation 10165 McKellar Court San Diego, CA 92121 U.S.A.
Device Classification:
The device, CARDS Q.S. hCG Serum/Urine (also sold under the brand name Concise Performance Plus 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 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 and sensitive immunoassay for the qualitative detection of hCG in serum or urine. This test is intended for use as an aid in the diagnosis of early 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.
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Principle of the Test:
Serum or urine is added to the Reaction Unit. If hCG is present in the sample, a pink vertical line forms in the Read Result Window. This pink line, together with the pre-printed blue horizontal line, form a plus sign (+) to indicate a positive result. If hCG is not present in the sample, the Read Result Window shows only the pre-printed blue horizontal line, forming a minus sign (-) to indicate negative result.
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 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 another FDA-cleared device 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 greater than 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.
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Image /page/2/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 symbol, which is a stylized representation of a human figure embracing another. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol. The text is in all caps and is evenly spaced around the circle.
NOV 26 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Robin Weiner . Vice President, Clinical Develop. & Reg. Affairs OUIDEL Corporation 10165 Mc Kellar Court 92121 San Diego, California
Re : K973858 CARDS® Q.S.® hCG-Serum/Urine; Concise® Performance Plus™ hCG-Combo Requlatory Class: II Product Code: JHI Dated: October 7, 1997 Received: October 9, 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, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರಿ 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 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 regulations.
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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 requlation (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 Other general premarket notification" (21 CFR 807.97). 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 Bitman
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
510(k) Number (if known):
9738558
CARDS® Q.S.® hCG Serum/Urine; and Concise® Performance. Plus™ hCG-Combo
Device. Name:
Indications for Use:
The CARDS® Q.S.® hCG Serum/Urine (also sold under the brand name Concise® Performance Plus™ 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.
(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. 973858
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use_
(Optional Format 1-2-96)