(35 days)
K#923925/A
K#923925/A
No
The device description details a standard immunochromatographic assay with no mention of AI or ML components. The mechanism relies on chemical reactions and visual interpretation of bands.
No.
The device is for the early detection of pregnancy by measuring hCG, not for treating or preventing any disease or condition.
Yes
The device is intended for the early detection of pregnancy by measuring hCG, and a clinical study concludes that it is "effective in diagnosing pregnancy."
No
The device description clearly outlines a physical immunochromatographic test strip that uses chemical reactions and visual indicators (purple bands) to detect hCG in a urine sample. This involves hardware components (wick, pads, membrane, antibodies) and is 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 the "early detection of pregnancy" by measuring hCG in a "urine sample." This is a diagnostic purpose performed in vitro (outside the body) on a biological specimen.
- Device Description: The description details an "immunochromatographic test" that detects an analyte (hCG) in a biological sample (urine) using antibodies. This is a common method for in vitro diagnostic tests.
- Mechanism of Action: The process described involves chemical reactions and the detection of a substance in a sample to determine a medical condition (pregnancy). This is the core function of an IVD.
- Clinical Trials: The mention of clinical trials comparing it to another device and concluding its effectiveness in "diagnosing pregnancy" further confirms its diagnostic nature.
- Predicate Devices: The listed predicate devices are also known IVD pregnancy tests.
Therefore, based on the intended use, device description, and the context of its function, this device clearly falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
An OTC hCG Pregnancy Test for home use intended for the early detection of pregnancy. It is intended to measure hCG, a placental hormone, in urine sample.
Product codes
Not Found
Device Description
The Sure Check™ Pregnancy Test is a self contained immunochromatographic test designed for use in detecting hCG in urine samples. After the person wets the wick in the device the urine is absorbed and transferred to a pad where a labelled colloidal gold containing a monoclonal antibody directed against beta hCG is present. If the antigen (hCG) is present, an antigen/antibody reaction takes place forming a complex. This migrates along the nitrocellulose support to the Test Line which is printed on the membrane. This is another antibody, in this case a monoclonal anti-hCG antibody, which captures the colored complex when it passes over the immobilized test line antibody. As the complex adheres to the capture antibody a visible light to dark purple band appears indicating a positive test result. The remaining complex travels further along the membrane to another immobilized control antibody. This captures the remaining complex forming another purple band indicating that the test has been performed properly.
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
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
Not Found
Summary of Performance Studies
The Sure Check™ Pregnancy Test was compared in clinical trials to the Chembio HCG STAT-PAK, K#923925/A.
Non-Clinical Tests:
- Sensitivity/Detection Limit Study Exhibit #6 a.
- Specificity Study Exhibit #7 b.
- Interfering Substance Study Exhibit #8 C.
- Time Study For Holding the Device in the Urine Stream Exhibit #9 d.
- Optimal Reaction Time Study Exhibit #10 0.
- f. Reproducibility Study - Exhibit #11
- Linearity Study Exhibit #12 0
Clinical Tests:
"Comparative Study Data: Accuracy as Determined by Correlation of Proposed Device with Currently Marketed Device (Professional Use)" - "Clinical Trial Report: An Open Study to Evaluate the Ability of Sure Check™ to Determine Pregnancy" - Study Conducted and Monitored by: Target Health Inc., 310 Madison Avenue, 22nd Floor, New York, NY 10017, concluding that our device is effective in diagnosing pregnancy.
Key Metrics
Sensitivity, Specificity, Reproducibility, Linearity
Predicate Device(s)
K#923925/A, Clearblue Easy Pregnancy Test, E.P.T. Pregnancy Test
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
EXHIBIT #1 Page 1 of 3
K96/965
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.
The assigned 510(k) number is:
1. Submitter's Identification:
Mr. Paul Reiter Chief Operating Officer Chembio Diagnostic Systems, Inc. 3661 Horseblock Road Medford, NY 11763
Date Summary Prepared: May 14, 1996
2. Name of the Device:
Sure Check™ Pregnancy Test
3. Predicate Device Information:
Chembio HCG STAT-PAK, K#923925/A Clearblue Easy Pregnancy Test, E.P.T. Pregnancy Test
4. Device Description:
The Sure Check™ Pregnancy Test is a self contained immunochromatographic test designed for use in detecting hCG in urine samples. After the person wets the wick in the device the urine is absorbed and transferred to a pad where a labelled colloidal gold containing a monoclonal antibody directed against beta hCG is present. If the antigen (hCG) is present, an antigen/antibody reaction takes place forming a complex. This migrates along the nitrocellulose support to the Test Line which is printed on the membrane. This is another antibody, in this case a monoclonal anti-hCG antibody, which captures the colored complex when it passes over the immobilized test line antibody. As the complex adheres to the capture antibody a visible light to dark purple band appears indicating a positive test result. The remaining complex travels further along the membrane to another immobilized control antibody. This captures the remaining complex forming another purple band indicating that the test has been performed properly.
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5. Intended Use:
An OTC hCG Pregnancy Test for home use intended for the early detection of pregnancy. It is intended to measure hCG, a placental hormone, in urine sample.
6. Comparison to Predicate Devices:
The Sure Check™ Pregnancy Test was compared in clinical trials to the Chembio HCG STAT-PAK, K#923925/A.
The Sure Check™ Pregnancy Test is designed as a home use midstream test where the sample is added via urinating directly onto an absorbent wick. The sample is transferred to the reactive membrane via this membrane where the reactions take place as described above. The HCG STAT-PAK utilizes the same immunochromatographic principle as described in Section 4-Device Description with the exception that the sample is collected in a cup/container and added via a dropper supplied with the kit. However, aside from the method in which the sample is added to the membrane, there are no differences in the chemistry between the tests.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Sure Check™ Pregnancy Test in the intended environment of use is supported by testing that was conducted in accordance with the FDA's Clinical Chemistry's "Draft-Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs), " 9/27/95.
The following testing was conducted by Chembio Diagnostic Systems, Inc. personnel:
- Sensitivity/Detection Limit Study Exhibit #6 a.
- Specificity Study Exhibit #7 b.
- Interfering Substance Study Exhibit #8 C.
- Time Study For Holding the Device in the Urine Stream Exhibit #9 d.
- Optimal Reaction Time Study Exhibit #10 0.
- f. Reproducibility Study - Exhibit #11
- Linearity Study Exhibit #12 0
2
None of the testing demonstrated any design characteristics that deviated from the requirements of the Reviewer Guidance or resulted in any safety or effectiveness concerns.
Discussion of Clinical Tests Performed: 8.
The Sure Check® Pregnancy Test was compared in clinical trials to the Chembio HCG STAT-PAK. Please refer to Exhibit #3. "Comparative Study Data: Accuracy as Determined by Correlation of Proposed Device with Currently Marketed Device (Professional Use)" - "Clinical Trial Report: An Open Study to Evaluate the Ability of Sure Check™ to Determine Pregnancy" - Study Conducted and Monitored by: Target Health Inc., 310 Madison Avenue, 22nd Floor, New York, NY 10017, concluding that our device is effective in diagnosing pregnancy.
9. Conclusions:
Our testing demonstrated that the Sure Check™ Pregnancy Test is as safe and effective as the predicate device for the intended use of the device.