(42 days)
Perfecta Pregnancy Test is a pregnancy test intended for home use.
Perfecta Pregnancy Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
The provided text describes a 510(k) summary for the "Perfecta™ Pregnancy Test" by Wyntek Diagnostics Inc. While it outlines the product's intended use, description, and claims of substantial equivalence, it does not contain specific information about acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot fulfill your request for the detailed table and study information based on the input provided. The text lacks:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used for test or training sets.
- Training set sample size or how its ground truth was established.
The document primarily focuses on regulatory submission details like contact information, product name, intended use, and substantial equivalence claims, without delving into the specifics of performance validation studies.
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Image /page/0/Picture/0 description: The image shows the text "KA65184" in a bold, handwritten font. The text is underlined with a thick, dark line. The characters are distinct and legible, with a slight slant to the right.
2 619.452.3198
6 619.452.3258
Image /page/0/Picture/1 description: The image shows the Wyntek diagnostics logo. The logo consists of a circular icon on the left and the company name on the right. The icon features a circle with a smaller circle at the top and two wing-like shapes extending from the bottom. The text "Wyntek" is in a bold, sans-serif font, with the word "diagnostics" in a smaller font below it.
EB - 4 1997
510 (k) Summary 8.
Wyntek Diagnostics Inc.
ISO9001 EN46001 Certified
6146 Nancy Ridge Drive Suite 101 San Diego California 92121 USA
- Wyntek Diagnostics, Inc. Submitter : 6146 Nancy Ridge Dr. Ste. 101 San Diego, CA 92121 Tel: 619-452-3198 Fax: 619-452-3258
Contact Person: Shu-Ching Cheng
Product Name:
Proprietary Name: Common Name: Classification Name: Classification Number: Perfecta™ Pregnancy Test OTC Pregnancy Test Kit Kit, Test, Pregnancy, HCG, OTC 75LCX
Intended Use: Perfecta Pregnancy Test is a pregnancy test intended for home use.
Description: Perfecta Pregnancy Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
Substantial Equivalence:
Perfecta Pregnancy Test is substantially equivalent to Abbott TestPack Plus hCG Urine Test, Warner-Lambert e.p.t Pregnancy Test and Carter Wallace FIRST RESPONSE Pregnancy Test. All these tests utilize immunochromatographic technology and anti-hCG antibodies to detect hCG in urine. All three tests interpret the results through the development of the color lines.
Applicant Signed: SL- Un Ch Date: 14/97 Shu-Ching Cheng
§ 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.