(42 days)
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No
The device description and lack of mentions of AI/ML or related concepts indicate it's a standard immunochromatographic test.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a diagnostic test that detects pregnancy, not treats or prevents anything.
Yes
The device is a pregnancy test, which diagnoses pregnancy.
No
The device description explicitly states it uses "color immunochromatographic technology with antibodies coated on the membrane," which describes a physical test strip, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "pregnancy test intended for home use." Pregnancy tests analyze biological samples (urine in this case) to provide information about a physiological state (pregnancy).
- Device Description: The description explains that it uses "color immunochromatographic technology with antibodies coated on the membrane" and detects "hCG is present in urine." This describes a method for analyzing a biological sample (urine) to detect a specific analyte (hCG) for diagnostic purposes.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Perfecta Pregnancy Test is a pregnancy test intended for home use.
Product codes
75LCX
Device 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.
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
home use
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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
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