(37 days)
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No
The device description and performance studies describe a standard lateral-flow immunoassay with visual interpretation, and there is no mention of AI or ML in the document.
No.
The device is a rapid immunoassay for the qualitative detection of hCG in urine, intended for the early detection of pregnancy, which is a diagnostic purpose, not a therapeutic one.
Yes
The device detects hCG in urine for the early detection of pregnancy, which is a diagnostic purpose.
No
The device description clearly states it is a "sandwich-format, lateral-flow immunoassay," which is a physical test strip that uses antibodies and chemical reactions to detect hCG. This involves hardware components, not just 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 hCG in urine" and "for the early detection of pregnancy." This is a diagnostic purpose performed on a sample taken from the human body (urine).
- Device Description: The description details a "rapid immunoassay" and a "sandwich-format, lateral-flow immunoassay," which are common technologies used in IVD tests.
- Performance Studies: The document describes studies comparing the device to "other FDA-cleared devices for qualitative hCG detection," which are inherently IVDs. It also mentions testing on "urine samples obtained from women presenting for pregnancy testing," further indicating its use in a diagnostic context.
- Intended User/Care Setting: The intended users are "health care professionals" and the setting is a "Physician's Office Laboratory," which are typical environments for performing IVD tests.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device clearly fits that definition.
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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 CARDS® Q.S.® hCG-Urine (also sold under the brand name Concises for the qualitative detection of human chorionic Intended - 101 - and of the early detection of pregnancy. The test is intended for use by health care professionals.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
The device, CARDS Q.S. hCG-Urine (also sold under the brand name Concise Performance Plus hCG-Urine), is similar to other FDA-cleared devices used for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The test is used in the early detection of pregnancy and is intended to measure hCG, a placental hormone, in urine (21 CFR 862.1155).
The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. Shortly after addition of the urine sample, a blue procedural Control Line will appear. If hCG is present in the sample, a pinkto-purple Test Line intersecting the pre-printed horizontal blue line will also appear. The result is read at three minutes after sample application. If no blue procedural Control Line develops, the result is considered invalid.
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
Primary intended user: 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
- 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.
- Physician's Office Laboratory studies were conducted in three geographically distinct sites in the United States.
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.
- Accuracy exceeding 99% was observed when compared to other FDA-cleared devices for qualitative hCG detection.
- Results obtained at each Physician's Office Laboratory study site agreed greater than 99% with the expected results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Accuracy: exceeding 99%
- Agreement: greater than 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.
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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.
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