(43 days)
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No
The summary describes a standard immunoassay pregnancy test and does not mention any AI or ML components.
No
The device is intended for detection and diagnosis (detecting hCG for pregnancy confirmation), not for treating or preventing a disease or condition.
Yes
The device is described as detecting the presence of hCG to confirm pregnancy, which is a diagnostic purpose.
No
The device description clearly indicates it is an immunoassay, which is a laboratory technique involving biological components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for detecting the presence of Human Chorionic Gonadotropin (hCG) in Urine. This is a biological sample taken from the body.
- Device Description: It's described as an "Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine". Immunoassays are a common type of in vitro diagnostic test.
- Analyte: It detects hCG, which is a "well known and established analyte used to confirm pregnancy". Analytes are substances measured in biological samples.
These points clearly indicate that the device is designed to perform a test on a biological sample (urine) outside of the body to provide diagnostic information (pregnancy status). This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quickstick™ One Step HCG Pregnancy Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. HCG is a well known and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration.
Product codes
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Device Description
Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Early Pregnancy
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
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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 product performance characteristics of the QuickstickTM One Step HCG Pregnancy Test were evaluated in a clinical sample correlation study and a blind labeled spiked HCG study. The results of these studies demonstrate the Phamatech QuicstickTM One Step HCG Pregnancy Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of early pregnancy. Correlations studies, using clinical specimens, produced a >99% correlation when compared to the Quidel Rapidvue (San Diego, CA 92121) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083). A blind labeled spiked consumer study was performed, the Phamatech QuickstickTM exhibited excellent sensitivity (79/79), specificity (79/79), and accuracy (158/158) in the hands of lay users.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (79/79), specificity (79/79), and accuracy (158/158)
Predicate Device(s)
Unipath Clearview HCG, Abbott Laboratories' Fact Plus, Syntron Bioresearch Be Sure Pregnancy Test
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.
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Image /page/0/Picture/1 description: The image shows a logo for "PHAMATECH". The logo consists of two large letters, "P" and "T", with the "P" slightly overlapping the "T". Below the letters, the word "PHAMATECH" is written in a smaller, sans-serif font. The entire logo is in black and white.
JUL 23 1996
9265 Activity Road, # 112/113 San Diego, California 92126 USA Tel: (619) 635-5840 Fax: (619) 635-5843
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickstickTM One Step HCG Pregnancy Test ldentification:
Immunoassay for the Qualitative Detection of Human Chorionic Description: Gonadotropin (hCG) in Urine for the Early Pregnancy
Manufacturer: Phamatech 9265 Activity Road #112, San Diego, California 92126, USA
Intended Use: The Quickstick™ One Step HCG Pregnancy Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. HCG is a well known and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration.
The Quickstick TM One Step HCG Pregnancy Test, like many Technology: commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Unipath Clearview HCG (Mountainview, CA 94043), Abbott Laboratories' Fact Plus (Abbott Park, IL 60064) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / HCG / antibody / complexes.
The product performance characteristics of the QuickstickTM One Performance: Step HCG Pregnancy Test were evaluated in a clinical sample correlation study and a blind labeled spiked HCG study. The results of these studies demonstrate the Phamatech QuicstickTM One Step HCG Pregnancy Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of early pregnancy. Correlations studies, using clinical specimens, produced a >99% correlation when compared to the Quidel Rapidvue (San Diego, CA 92121) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083). A blind labeled spiked consumer study was performed, the Phamatech QuickstickTM exhibited excellent sensitivity (79/79), specificity (79/79), and accuracy (158/158) in the hands of lay users.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickstickTM One Step HCG Pregnancy Test is substantially equivalent to a variety of pregnancy tests currently in commercial distribution.