(29 days)
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No
The device description and performance studies focus on antibody technology and visual interpretation of results, with no mention of AI or ML.
No
The device is described as an immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. It is a diagnostic tool, not a therapeutic one.
Yes
The device is described as "a rapid, one step immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy" and states that the presence of hCG is used "in the diagnosis of pregnancy," which directly implies its use in diagnosing a medical condition.
No
The device description clearly states it is a "dipstick format" and involves a "Test Strip" which are physical components, indicating it is a hardware-based immunoassay, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative detection 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.
- Device Description: The description details how the device works by detecting hCG in urine using antibody technology. This is a characteristic of an in vitro diagnostic test.
- Sample Type: The device uses urine, which is a biological specimen.
- Purpose: The purpose is to diagnose pregnancy, which is a medical condition.
- Care Setting: It is intended for "Laboratory and Professional Use," indicating it is used in a clinical or laboratory setting for diagnostic purposes.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Scripps Laboratories hCG One-Step is a rapid, one step immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory and Professional Use.
Product codes
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Device Description
HCG is a hormone produced and secreted by the placenta following implantation. Its early presence and rapid increase in maternal urine make it an excellent marker for use in the diagnosis of pregnancy.
Scripps Laboratories hCG One-Step uses monoclonal and polyclonal antibody technology to specifically detect hCG in urine.
The product is configured in a dipstick format. When the product is partially submerged in urine, the sample travels through the Test Strip. If hCG is present at levels of 25 mIU/ml (W.H.O. 3rd I.S. 75/537) or greater, a positive result, two distinct red bands will appear. If no hCG is present, a negative result, one red band, will appear.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory and Professional
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Accuracy: Scripps Laboratories hCG One-Step was evaluated and compared to a commercially available visual hCG test in a multicenter field study. Five hundred seven urine specimens presented for pregnancy testing were run on Scripps Laboratories hCG One-Step and designated as qualitatively positive or negative for hCG based on the results of Quidel® Quick Vue® One-Step hCG Urine Test. All testing was performed in the intended use setting by individuals with different educational backgrounds and training. The clinical accuracy of Scripps Laboratories hCG One-Step in the intended use setting was 99.8% when compared to a commercially available visual hCG test.
Sensitivity: Urine samples with hCG concentrations of 25 mIU/ml (W.H.O. 3rd I.S. 75/537) or greater yielded positive results on Scripps Laboratories hCG One-Step.
Interference: The following substances were added to urine containing either 0 mIU/ml or 25 mIU/ml hCG and did not interfere with the performance of Scripps Laboratories hCG One-Step at the concentrations indicated: Acetaminophen (20 mg/dl), Acetylsalicylic Acid (20 mg/dl), Ampicillin (4 mg/dl), Atropine (20 mg/dl), Caffeine (20 mg/dl), Ephedrine (20 mg/dl), Ethylenediaminetetraacetic Acid (80 mg/dl), Gentisic Acid (20 mg/dl), Ibuprofen (20 mg/dl), Ethanol (10%), Phenylpropanolamine HCl (4000 mg/dl), Tetracycline (20 mg/dl). Urine Analytes: Albumin, human (2000 mg/dl), Ascorbic Acid (20 mg/dl), Bilirubin (1 mg/dl), Creatinine (200 mg/dl), Estradiol (25 ng/ml), Estriol (25 ng/ml), Glucose (2000 mg/dl), Hemoglobin (500 mg/dl), β-Hyroxybutyric Acid (100 mg/dl), Pregnanediol (1000 ng/ml), Progesterone (40 ng/ml), Riboflavin (3750 µg/dl), Uric Acid (10 mg/dl).
Cross Reactivity: The addition of 500 mIU/ml LH, 1000 mIU/ml FSH, and 1000 μIU/ml TSH to samples containing either 0 mIU/ml or 25 mIU/ml hCG did not exhibit cross reactivity in Scripps Laboratories hCG One-Step.
Urine pH: Urine samples containing either 0 mIU/ml or 25 mIU/ml hCG adjusted to different pH levels from 4 to 9 did not affect the performance of Scripps Laboratories hCG One-Step.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 100%
Specificity: 99.6%
Accuracy: 99.8%
Predicate Device(s)
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
AUG 2 3 1006
Scripps Laboratories hCG One-Step 510(k) Notification
SECTION VI.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1
Image /page/1/Picture/0 description: The image shows the logo for Scripps Laboratories. The logo consists of the word "SCRIPPS" in large, bold, sans-serif font, with a small circle above the "I". Below the word "SCRIPPS" is the word "LABORATORIES" in a smaller, sans-serif font. The logo is black and white.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS VI.
- Submitter Identification A.
- Name and Address l.
Scripps Laboratories, Inc. 6838 Flanders Drive San Diego, CA 92121
-
- Contact Person
Noreen E. Leamon
- Contact Person
-
- Phone Numbers
Voice: (619) 546-5800 FAX: (619) 546-5812
- Phone Numbers
-
- Date of Submission
July 22, 1996
- Date of Submission
-
Names of Device B.
- l. Proprietary Name
SCRIPPS LABORATORIES hCG One-Step
-
- Common Name
A Rapid, One-Step Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Early Detection of Pregnancy.
- Common Name
-
- Classification Name
Human Chorionic Gonadotropin (hCG) Test System.
- Classification Name
-
Legally Marketed Devices to Which Substantial Equivalence is C. Claimed
2
Image /page/2/Picture/0 description: The image shows the logo for Scripps Laboratories. The logo consists of the word "SCRIPPS" in large, bold, sans-serif font, with a small circle above the "I". Below the word "SCRIPPS" is the word "LABORATORIES" in a smaller, sans-serif font. The logo is black and white.
- D. Description
HCG is a hormone produced and secreted by the placenta following implantation. Its early presence and rapid increase in maternal urine make it an excellent marker for use in the diagnosis of pregnancy.
Scripps Laboratories hCG One-Step uses monoclonal and polyclonal antibody technology to specifically detect hCG in urine.
The product is configured in a dipstick format. When the product is partially submerged in urine, the sample travels through the Test Strip. If hCG is present at levels of 25 mIU/ml (W.H.O. 3rd I.S. 75/537) or greater, a positive result, two distinct red bands will appear. If no hCG is present, a negative result, one red band, will appear.
-
E. Intended Use Statement
Scripps Laboratories hCG One-Step is a rapid, one step immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory and Professional Use. -
F. Summary of Similarities to Legally Marketed Devices
Scripps Laboratories hCG One-Step is substantially equivalent in methodology, intended use, technology and performance characteristics to Quidel® Quick Vue® One-Step hCG Urine Test and to Wyntek Diagnostics OSOM™ hCG-Urine Test. The similarities between the three tests are shown in the following table.
3
Image /page/3/Picture/0 description: The image shows the logo for Scripps Laboratories. The word "SCRIPPS" is in a large, bold, sans-serif font, with a dot above the "I". Below that, the word "LABORATORIES" is in a smaller, sans-serif font. The logo is black and white.
Summary of Similarities Between Scripps Laboratories hCG One-Step. Quidel® QuickVue® One-Step hCG Urine Test and Wyntek Diagnostics OSOM™ hCG-Urine Test.
| Characteristic | Scripps
Laboratories hCG
One-Step | Quidel®
QuickVue® One-
Step hCG Urine
Test | Wyntek
Diagnostics
OSOM™ hCG-
Urine Test |
|---------------------------|-------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------|
| Intended Use | | | |
| Diagnostic Use | Early Detection of
Pregnancy | Early Detection of
Pregnancy | Early Detection of
Pregnancy |
| Use Setting | Laboratory and
Professional | Laboratory and
Professional | Laboratory and
Professional |
| Methodology | | | |
| Sample | Urine | Urine | Urine |
| Timing | 5 minutes | 3 minutes | 1 minute |
| Format | One-Step | One-Step | One-Step |
| Results
Interpretation | Visual, Qualitative | Visual, Qualitative | Visual, Qualitative |
| Detection Limit | 25 mIU/ml | 25 mIU/ml | 25 mIU/ml |
| Standardization | WHO 3rd IS 75/537 | WHO 3rd IS 75/537 | WHO 3rd IS 75/537 |
| Technology | | | |
| Assay Type | Chromatographic
Immunoassay | Chromatographic
Immunoassay | Chromatographic
Immunoassay |
| Antibodies | Murine Monoclonal
and Caprine
Polyclonal Anti-
hCG | Murine Monoclonal
and Caprine
Polyclonal Anti-
hCG | Murine Monoclonal
and Rabbit
Polyclonal Anti-
hCG |
| Solid Phase | Membrane | Membrane | Membrane |
| Performance | | | |
| Sensitivity | 100% | 99.5% | 99.6% |
| Specificity | 99.6% | 99.6% | 99.6% |
| Accuracy | 99.8% | 99.5% | 99.6% |
4
Image /page/4/Picture/0 description: The image shows the logo for Scripps Laboratories. The word "SCRIPPS" is in large, bold, black letters, with a black dot above the "I". Below that, in smaller, black letters, is the word "LABORATORIES". The logo is simple and professional.
- G. Performance Data
-
- Clinical Accuracy
-
Scripps Laboratories hCG One-Step was evaluated and compared to a commercially available visual hCG test in a multicenter field study. Five hundred seven urine specimens presented for pregnancy testing were run on Scripps Laboratories hCG One-Step and designated as qualitatively positive or negative for hCG based on the results of Quidel® Quick Vue® One-Step hCG Urine Test. All testing was performed in the intended use setting by individuals with different educational backgrounds and training.
The clinical accuracy of Scripps Laboratories hCG One-Step in the intended use setting was 99.8% when compared to a commercially available visual hCG test. The sensitivity was 100% and the specificity was 99.6%.
Clinical Accuracy of Scripps Laboratories hCG One-Step
Image /page/4/Figure/8 description: The image shows a table titled "Comparative Test" with data related to hCG testing. The table is a 2x2 matrix, with rows and columns labeled '+' and '-'. The cells contain the numbers 238, 1*, 0, and 268. A note indicates that the sample contained 17.9 mIU/ml hCG, and the test was performed by Scripps Laboratories using hCG One-Step.
2. Sensitivity
Urine samples with hCG concentrations of 25 mIU/ml (W.H.O. 3rd I.S. 75/537) or greater yielded positive results on Scripps Laboratories hCG One-Step.
-
- Interference
The following substances were added to urine containing either 0 mIU/ml or 25 mIU/ml hCG and did not interfere with the performance of Scripps Laboratories hCG One-Step at the concentration indicated:
- Interference
5
Image /page/5/Picture/0 description: The image shows the logo for Scripps Laboratories. The word "SCRIPPS" is in large, bold, sans-serif font, with a dot above the second "I". Below that, in a smaller font, is the word "LABORATORIES". The logo is black and white.
- Performance Data (continued) G.
- 3. Interference (continued)
| Drug/Chemical | Concentration |
|---|---|
| Acetaminophen | 20 mg/dl |
| Acetylsalicylic Acid | 20 mg/dl |
| Ampicillin | 4 mg/dl |
| Atropine | 20 mg/dl |
| Caffeine | 20 mg/dl |
| Ephedrine | 20 mg/dl |
| Ethylenediaminetetraacetic Acid | 80 mg/dl |
| Gentisic Acid | 20 mg/dl |
| Ibuprofen | 20 mg/dl |
| Ethanol | 10% |
| Phenylpropanolamine HCl | 4000 mg/dl |
| Tetracycline | 20 mg/dl |
| Urine Analyte | Concentration |
|---|---|
| Albumin, human | 2000 mg/dl |
| Ascorbic Acid | 20 mg/dl |
| Bilirubin | 1 mg/dl |
| Creatinine | 200 mg/dl |
| Estradiol | 25 ng/ml |
| Estriol | 25 ng/ml |
| Glucose | 2000 mg/dl |
| Hemoglobin | 500 mg/dl |
| β-Hyroxybutyric Acid | 100 mg/dl |
| Pregnanediol | 1000 ng/ml |
| Progesterone | 40 ng/ml |
| Riboflavin | 3750 µg/dl |
| Uric Acid | 10 mg/dl |
4. Cross Reactivity
The addition of 500 mIU/ml LH, 1000 mIU/ml FSH, and 1000 μIU/ml TSH to samples containing either 0 mIU/ml or 25 mIU/ml hCG did not exhibit cross reactivity in Scripps Laboratories hCG One-Step.
6
Image /page/6/Picture/0 description: The image shows the logo for Scripps Laboratories. The logo consists of the word "SCRIPPS" in large, bold, sans-serif font, with a small black circle above the "I". Below "SCRIPPS" is the word "LABORATORIES" in a smaller, sans-serif font. The logo is black and white.
- G. Performance Data (continued)
- Urine pH న.
Urine samples containing either 0 mIU/ml or 25 mIU/ml hCG adjusted to different pH levels from 4 to 9 did not affect the performance of Scripps Laboratories hCG One-Step.