(34 days)
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No
The device description details a simple lateral-flow immunoassay with visual interpretation of results based on the presence or absence of colored lines. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML.
No
The device is described as a rapid immunoassay for the qualitative detection of hCG in urine, intended as an aid in the early detection of pregnancy. It does not treat, mitigate, prevent, or cure any disease or condition.
Yes
Explanation:
The device is a rapid immunoassay for the qualitative detection of hCG in urine as an aid in the early detection of pregnancy. This directly indicates its use in diagnosing pregnancy.
No
The device description clearly describes a physical, lateral-flow immunoassay test strip that produces visible results based on chemical reactions. There is no mention of any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states the test is for the "qualitative detection of hCG in urine as an aid in the early detection of pregnancy." This involves analyzing a biological sample (urine) outside of the body to provide diagnostic information.
- Device Description: It describes a "rapid immunoassay" and a "sandwich-format, lateral-flow immunoassay" that employs antibodies to detect a specific substance (hCG) in the urine sample. This is a common method used in IVD tests.
- Sample Type: The test uses urine, which is a biological specimen.
- Purpose: The purpose is to aid in the early detection of pregnancy, which is a diagnostic purpose.
The fact that it's intended for "over the counter home use" and is a "one-step immunoassay" further confirms its nature as a consumer-friendly IVD.
N/A
Intended Use / Indications for Use
The test is a rapid immunoassay for the qualitative detection of hCG in urine as an aid in the early detection of pregnancy. The test is intended for overthe counter home use.
The Bluetest® Pregnancy Test, also sold under the brandname RapidVue® Pregnancy Test, is a one-step immunossay intended for the qualitative detection of hCG in urine for the early detection of pregnancy. The Bluetest® Pregnancy Test, is a one-step immunessay intended for the qualitative detection of hCG in urine for the early detection of pregnancy and is intended for overthe counter home use.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. If the sample contains hCG, a pink and blue plus sign (+) is visible in the large Result Window, along with a blue line in the small Control Window to indicate a positive result. If hCG is not present in the sample, a blue minus sign (-) is visible in the large Result Window, along with a blue line in the small Control Window, to indicate a negative result.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use
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
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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 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 was conducted in a multi-center clinical study.
- A consumer study was conducted in order to show that lay users could read the package insert, perform the test in their home and obtain results similar to results obtained by clinic personnel.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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JAN 26 1998
SUMMARY OF SAFETY AND EFFECTIVENESS XI.
Product
Bluetest® Pregnancy Test; or RapidVue® Pregnancy Test
Manufacturer
OUIDEL Corporation 10165 McKellar Court San Diego, CA 92121 U.S.A.
Device Classification
Device, Bluetest Pregnancy Test, also sold under the brandname Rapid Vue Pregnancy Test, is similar to other FDA-cleared devices used for the qualitative detection of human chorionic gonadotropin (hCG). The test is used in the early detection of pregnancy and is intended to measure hCG, a abea in all comone, in 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 urine as an aid in the early detection of pregnancy. The test is intended for overthe counter home use.
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
The test, a sandwich-format, lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. If the sample contains hCG, a pink and blue plus sign (+) is visible in the large Result Window, along with a blue line in the small Control Window to indicate a positive result. If hCG is not present in the sample, a blue minus sign (-) is visible in the large Result Window, along with a blue line in the small Control Window, to indicate a 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. These studies included the following:
- · The test was shown to be similar to other commercially distributed 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 was conducted in a multi-center clinical study.
- · A consumer study was conducted in order to show that lay users could read the package insert, perform the test in their home and obtain results similar to results obtained by clinic personnel.
Conclusion
These studies demonstrated the substantial equivalence of the test to existing products already marketed. They further demonstrated the suitability of the product for over-the-counter home use. 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 shows the logo for Health & Human Services, USA. The logo is a circular emblem with the words "HEALTH & HUMAN SERVICES, USA" arranged in an arc at the top. Below the text is a stylized image of an eagle with its wings spread, and the number 136 is at the bottom.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 26 1998
. Robin Weiner Vice President, Clinical Develop. & Reg. Affairs QUIDEL Corporation 10165 McKellar Court San Diego, California 92121
K974821 Re : Bluetest® Pregnancy Test; or RapidVue® Pregnancy Test Regulatory Class: II Product Code: LCX Dated: December 22, 1997 December 23, 1997 Received:
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 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 General regulation (21 CFR Part 820) and that, Devices: 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 (CDIA-66), Child device if it does, you should contact Cacegorization: - 10 asse 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 described in your sit (x, privalence 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 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 Litman
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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510(k) Number (if known): J
Bluetest® Pregnancy Test; or Bluetes. Pregnancy Test
Device Name:
Indications for Use:
The Bluetest® Pregnancy Test, also sold under the brandname The Bluetest® Pregnancy Test, is a one-step immunossay intended for RapidVue® Pregnancy Test, is a one-step immunessay detection of
the qualitative detection of hCG in urine. for the early detection of
the qualitative the intended for overshe the qualitative detection of hCG in urine for the vely and
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
S CONTINER IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Kmoor for Montgomery (Division Sign-Off) | |
|---|---|
| Division: | Clinical Laboratory Devices |
| 510(k) Number | 974821 |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The Counter Use | ✓ |
|---|---|
| ---------------------- | --- |
Pr (Per 21 CFR 801.109)
(Optional Format 1-2-96)
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