(78 days)
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No
The device description details a chemical assay based on antibody binding and color change, with no mention of computational analysis, algorithms, or learning processes. The performance studies are standard clinical trial results comparing the device to predicates, not evaluating an AI/ML model.
No
The device is a diagnostic test used to detect the presence of hCG for pregnancy, not to treat or cure a medical condition.
Yes
Explanation: The device is intended for the detection of human chorionic gonadotropin (hCG) in urine to determine pregnancy. This detection is a qualitative assessment used to identify a physiological condition, which falls under the definition of a diagnostic device.
No
The device description clearly outlines a physical, chemical-based assay for detecting hCG in urine, involving absorbent material, antibodies, and color bands. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative, one-step assay for the detection of human chorionic gonadotropin (hCG) in urine." This describes a test performed in vitro (outside the body) on a biological sample (urine) to provide diagnostic information (presence of hCG, indicating pregnancy).
- Device Description: The description details the mechanism of action, which involves chemical reactions with components in the urine sample to detect hCG. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies evaluate the device's ability to accurately detect hCG in urine samples, using metrics like sensitivity, specificity, and accuracy. These are standard evaluations for IVD devices.
The fact that it's intended for use by the "lay consumer" (over-the-counter) doesn't change its classification as an IVD. Many IVDs are designed for home use.
N/A
Intended Use / Indications for Use
The Evidence Pregnancy Test is a qualitative, one-step assay for the detection of human chorionic gonadotropin (hCG) in urine. The Evidence Pregnancy Test is intended to be used by the lay consumer.
Product codes
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Device Description
Evidence Pregnancy Test is a pregnancy test to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the eighth or ninth day after fertilization. The Evidence Pregnancy Test will detect hCG in urine as early as the first day after a missed menses. The Evidence Pregnancy Test will be made available to the lay consumer.
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
lay consumer
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)
A clinical trial was done to confirm the performance of the Evidence Pregnancy Test. These data clearly demonstrate that the performance of the Evidence Pregnancy Test is substantially equivalent to the Hoffman La-Roche Pregnosis Pregnancy Test.
Pregnosis vs. Evidence (Professional User):
Sample Size: 100
Results:
EVIDENCE +: 95 Pregnosis +, 2 Pregnosis -
EVIDENCE -: 0 Pregnosis +, 3 Pregnosis -
Cards + Q.S. vs. Evidence (Professional User):
Sample Size: 2
Results:
Evidence +: 2 CARDS + Q.V. +, 0 CARDS + Q.S. -
Evidence -: 0 CARDS + Q.V. +, 0 CARDS + Q.S. -
Medical Technologist vs. Study Participant (Lay Consumer):
Study to confirm that the Evidence Pregnancy Test can be used by the lay consumer. 100 people were asked to perform the test. Study participants were asked to read the insert and perform the test as instructed.
Sample Size: 100
Results:
Study Participant+: 31 Medical Technologist +, 0 Medical Technologist -
Study Participant -: 0 Medical Technologist +, 69 Medical Technologist -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pregnosis vs. Evidence (Professional User):
Sensitivity = 100.00%
Specificity = 60.00%
Accuracy = 98.00%
% Negative Predictive Value = 100.00%
% Positive Predictive Value = 97.94%
Cards + Q.S. vs. Evidence (Professional User):
Sensitivity = 100.00%
Specificity = 100.00%
Accuracy = 100.00%
% Negative Predictive Value = 100.00%
% Positive Predictive Value = 100.00%
Medical Technologist vs. Study Participant (Lay Consumer):
Sensitivity = 100.00%
Specificity = 100.00%
Accuracy = 100.00%
% Negative Predictive Value = 100.00%
% Positive Predictive Value = 100.00%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
510k Submission (K962721) Evidence Pregnancy Test Universal Diagnostics L.L.C.
OCT 1 1996
Page 4 of 16
510 (K) SUMMARY
Date of Summary: September 12, 1996
Product Name:
Evidence Pregnancy Test
Sponsor's Name:
Universal Diagnostics L.L.C. P.O. Box 67635 Rancho Santa Fe, CA 92067
Manufactured by:
Veda Lab Rue de l' Expansion - ZAT du Londeau - CERISE B.P. 181 - 61006 Alencon Cedex, France
Correspondent:
MDC Associates Fran White Regulatory Consultant 15 Oak Street Beverly Farms, MA 01915
Substantially Equivalent Devices:
Product: Pregnosis Pregnancy Test Manufactured by: Hoffman - La Roche, Inc.
Product: Cards + Q.S. Pregnancy Test Manufactured by: Pacific Biotech, Inc., a subsidiary of Quidel Corporation
1
510k Submission K962721 Evidence Pregnancy Test Universal Diagnostics L.L.C.
PRODUCT DESCRIPTION:
Evidence Pregnancy Test is a pregnancy test to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the eighth or ninth day after fertilization. The Evidence Pregnancy Test will detect hCG in urine as early as the first day after a missed menses. The Evidence Pregnancy Test will be made available to the lay consumer.
INTENDED USE:
The Evidence Pregnancy Test is a qualitative, one-step assay for the detection of human chorionic gonadotropin (hCG) in urine. The Evidence Pregnancy Test is intended to be used by the lay consumer.
SUMMARY OF TECHNOLOGY:
The Evidence Pregnancy Test employs a unique combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine. As the urine flows through the absorbent portion of the device, the antibodydye conjugate binds to the hCG forming an antibody-antigen complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose color band if hCG concentration is greater than 25 mIU/ml. In the absence of hCG, there is no line in the positive reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a pink-rose color band, demonstrating that the reagents are functioning correctly.
2
510k Submission K962721 Evidence Pregnancy Test Universal Diagnostics L.L.C.
Page 6 of 16
PERFORMANCE DATA:
A clinical trial was done to confirm the performance of the Evidence Pregnancy Test. These data clearly demonstrate that the performance of the Evidence Pregnancy Test is substantially equivalent to the Hoffman La-Roche Pregnosis Pregnancy Test.
Pregnosis vs. Evidence (Professional User)
| PREGNOSIS + | PREGNOSIS - | Row Total | |
|---|---|---|---|
| EVIDENCE + | 95 | 2* | 97 |
| EVIDENCE - | 0 | 3 | 3 |
| Total | 95 | 5 | 100 |
| Sensitivity = | 100.00% |
|---|---|
| Specificity = | 60.00% |
| Accuracy = | 98.00% |
| % Negative Predictive Value = | 100.00% |
| % Positive Predictive Value = | 97.94% |
- Note: False positive results were tested with Pacific Biotech Cards + Q.S. and were confirmed positive. Both the Evidence Pregnancy Test and the Cards + Q.S. detect levels of hCG in urine at 25 mIU/ml. The Pregnosis Pregnancy Test will detect only 1.5 to 2.5 IU/ml of hCG in urine which is approximately 42 days after conception. The Evidence Pregnancy Test is more sensitive than the Pregnosis Test.
3
510k Submission K962721 Evidence Pregnancy Test
Universal Diagnostics L.L.C.
Page 7 of 16
Cards + Q.S. vs. Evidence (Professional User)
Data Summary
| CARDS + Q.V. + | CARDS + Q.S. - | Row Total | |
|---|---|---|---|
| Evidence + | 2 | 0 | 2 |
| Evidence - | 0 | 0 | 0 |
| Total | 2 | 0 | 2 |
| Sensitivity = | 100.00% |
|---|---|
| Specificity = | 100.00% |
| Accuracy = | 100.00% |
| % Negative Predictive Value = | 100.00% |
| % Positive Predictive Value = | 100.00% |
4
510k Submission K962721 Evidence Pregnancy Test Universal Diagnostics L.L.C.
Page 8 of 16
Medical Technologist vs. Study Participant
(Lay Consumer)
To confirm that the Evidence Pregnancy Test can be used by the lay consumer. 100 people were asked to perform the test. Study participants were asked to read the insert and perform the test as instructed.
The following is a summary of the test results.
| | Medical Technologist + | Medical
Technologist - | Row Total |
|-------------------------|------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study
Participant+ | 31 | 0 | 31 |
| Study
Participant - | 0 | રેતે | રેતે વિવેચા છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉત્પાદની ખેતી કરવામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમ |
| Total | 31 | રેને | 100 |
Data Summary
| Sensitivity = | 100.00% |
|---|---|
| Specificity = | 100.00% |
| Accuracy = | 100.00% |
| % Negative Predictive Value = | 100.00% |
| % Positive Predictive Value = | 100.00% |