(2 days)
Not Found
No
The summary describes a traditional in vitro diagnostic test strip read by a chemistry analyzer, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in-vitro diagnostic test strip used for the qualitative measurement of hCG to detect pregnancy, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as "for the qualitative measurement of Human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy," which directly indicates it is used for diagnostic purposes.
No
The device description explicitly states that the device is "unitized reagent strips" used with "Urine Chemistry Analyzers," indicating it is a physical test strip and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative measurement of Human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: It describes "reagent strips" used with "Urine Chemistry Analyzers," which are typical components of in vitro diagnostic systems.
- Performance Studies: The document mentions performance studies conducted according to FDA guidance for "Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVD's)."
- Predicate Devices: The listed predicate devices are also IVDs (pregnancy tests).
All of these points strongly indicate that the CLINITEK® hCG Test Strips are an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CLINITEK® hCG Test Strips are for the qualitative measurement of Human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. CLINITEK hCG Test Strips are for professional use in clinical laboratories, physician offices and other point-of-care healthcare locations.
Product codes
Not Found
Device Description
CLINITEK® hCG Test Strips are unitized reagent strips used with the CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers. Each bottle contains 25 test strips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use in clinical laboratories, physician offices and other point-of-care healthcare locations.
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
The performance of CLINITEK® hCG Test Strips was assessed according to the FDA Reviewer's Guidance Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVD's) and the National Committee for Clinical Laboratory Standards (NCCLS) guideline Chorionadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application Studies were performed in-house and in external field evaluations utilizing clinical urine specimens.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of the internal and external studies demonstrate that CLINITEK® hCG Test Strips are equivalent in performance to predicate devices currently in interstate commerce and suitable for use in point-of-care locations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Baver Corporation, Business Group Diagnostics CLINITEK® hCG Test Strips
510(k) Safety and Effectiveness Summary Page 1 of 2
CLINITEK® hCG Test Strips for
510(k) SAFETY AND EFFECTIVENESS SUMMARY
March 12, 1997 Prepared:
Submitter: Bayer Corporation, Business Group Diagnostics
- 1884 Miles Avenue, P. O. Box 70 Address: Elkhart, IN 46515 (219) 262-6929
- Rosanne M. Savol, R.A.C. Contact: Manager, Regulatory Affairs
- Device:
Detection of hCG in Urine Common/Usual Name: Urine Pregnancy Test Document Control Number: K97
Classification Name: Human Chorionic Gonadotropin (hCG) Test System
Trade/Proprietary Name:
- Predicate Devices: OuickVue® One-Step HCG Combo Manufactured by QUIDEL Corporation Test Pack +Plus hCG Combo Manufactured by Abbott Laboratories
- CLINITEK® hCG Test Strips are unitized reagent strips used with the Device Description: CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers. Each bottle contains 25 test strips.
- CLINITEK® hCG Test Strips are for the qualitative measurement of Intended Use: Human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. CLINITEK hCG Test Strips are for professional use in clinical laboratories, physician offices and other point-of-care healthcare locations.
1
Technological Characteristics:
The CLINITEK® hCG Test Strip uses immunochromatographic assay methods for detecting human chorionic gonadotropin (hCG) in urine. It is intended to be read instrumentally on the CLINITEK 50 and CLINITEK 100 Urine Chemistry Analyzers. The first zone of the test strip contains antibody to hCG (monoclonal anti-beta hCG) coupled with red dye. The urine rehydrates this zone and mobilizes the antibody-dye. Any hCG present will bind with the antibody-dye conjugate. Another zone of hCG specific antibodies (polyclonal anti-alpha hCG) is bound to the strip. As the hCGantibody-dye moves along the strip it will bind to this zone producing a red line (positive result). A similar migration pattern occurs with the built-in procedural control feature. A blue line appears which indicates that a sufficient amount of urine has saturated the test strip. If there is no hCG present in the urine only the blue line will appear (negative result). The CLINITEK 50 and CLINITEK 100 Urine Chemistry Analyzers are relectance photometers that analyze the color and intensity of the light reflected from the test strip. The algorithm in the instruments converts the measured reflectance and displays the results as either "positive" or "negative" on the instrument display panel. No calculations are required by the user.
Assessment of Performance:
The performance of CLINITEK® hCG Test Strips was assessed according to the FDA Reviewer's Guidance Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVD's) and the National Committee for Clinical Laboratory Standards (NCCLS) guideline Chorionadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application Studies were performed in-house and in external field evaluations utilizing clinical urine specimens.
Conclusion:
The results of the internal and external studies demonstrate that CLINITEK® hCG Test Strips are equivalent in performance to predicate devices currently in interstate commerce and suitable for use in point-of-care locations.
' Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVD's). Department of Health and Human Services, Food and Drug Administration. CDRH, 2098 Gatther Road, Rockville, MD 20850, 1995.
2 Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Proposed Guideline. National Committee for Clinical Laboratory Standards (NCCLS) Document I/LA10-P (ISBN 1-56238-275-6). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087, 1995.