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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Scripps Laboratories hCG One-Step device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, pre-defined set of targets. Instead, it presents performance characteristics for the Scripps Laboratories hCG One-Step and compares them to legally marketed devices. The implied acceptance criteria are that the device's performance should be comparable or superior to these predicate devices.

Performance Characteristic	Acceptance Criteria (Implied from predicate devices)	Reported Device Performance (Scripps Laboratories hCG One-Step)
Sensitivity	99.5% - 99.6%	100%
Specificity	99.6%	99.6%
Accuracy	99.5% - 99.6%	99.8%
Detection Limit	25 mIU/ml	25 mIU/ml
Timing	1-3 minutes	5 minutes
Standardization	WHO 3rd IS 75/537	WHO 3rd IS 75/537

Note on Timing: While the Scripps product takes 5 minutes, compared to 1 or 3 minutes for predicate devices, the other performance metrics (sensitivity, specificity, accuracy) are equal or better, suggesting this timing difference was not considered a significant hindrance to substantial equivalence.

2. Sample Size and Data Provenance for Test Set

Sample Size: 507 urine specimens.
Data Provenance: The data was collected in a "multicenter field study." The document does not explicitly state the country of origin but implies a clinical laboratory or professional setting within the US, as it's for 510(k) approval by the FDA. The study was prospective in the sense that the Scripps device was being evaluated against a commercial benchmark using new specimens presented for testing.

3. Number of Experts and Qualifications for Ground Truth

The document states that the ground truth for the test set was established by a "commercially available visual hCG test" (Quidel® Quick Vue® One-Step hCG Urine Test).
The actual individuals performing the initial interpretations are described as "individuals with different educational backgrounds and training." There is no specific number of "experts" defined for establishing the ground truth beyond the performance of the predicate device.

4. Adjudication Method for the Test Set

The adjudication method was based on the results of a single, commercially available predicate device: the Quidel® Quick Vue® One-Step hCG Urine Test. There's no mention of multiple expert adjudicators or a specific voting/consensus method (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study focuses on the standalone performance of the Scripps device compared to an existing device, not on the improvement of human readers with or without AI assistance. The device is a diagnostic test itself, not an AI-assisted interpretation tool for human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-loop)

Yes, a standalone performance study was done. The Scripps Laboratories hCG One-Step is a rapid, one-step immunoassay, meaning it produces a visual result directly. The performance data (sensitivity, specificity, accuracy) reflect the device's ability to correctly identify hCG levels independently. "Individuals with different educational backgrounds and training" performed the testing, suggesting human interpretation of the visual result, but the performance metrics are attributed to the device itself.

7. Type of Ground Truth Used

The ground truth used was established by a predicate commercial device's result. Specifically, the Quidel® Quick Vue® One-Step hCG Urine Test was considered the reference standard against which the Scripps Laboratories device was compared for "qualitatively positive or negative for hCG."

8. Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its sample size. This type of immunoassay usually undergoes extensive internal R&D and validation with various contrived and clinical samples to optimize its formulation and design. The data presented in this 510(k) summary represents a clinical validation (test set) of the final product.

9. How Ground Truth for the Training Set Was Established

As no dedicated "training set" is described, there's no information on how its ground truth would have been established. For the development of an immunoassay, the "ground truth" for internal optimization typically involves:

Using samples spiked with known concentrations of hCG.
Comparing results to highly accurate laboratory methods (e.g., quantitative immunoassay, mass spectrometry) or established reference standards.
Testing with known positive and negative clinical samples confirmed by other means.

Summary

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K962906

AUG 2 3 1006

Scripps Laboratories hCG One-Step 510(k) Notification

SECTION VI.

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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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

1. Contact Person
  Noreen E. Leamon
1. Phone Numbers
  Voice: (619) 546-5800 FAX: (619) 546-5812
1. Date of Submission
  July 22, 1996
Names of Device B.
- l. Proprietary Name

SCRIPPS LABORATORIES hCG One-Step

1. Common Name
  A Rapid, One-Step Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Early Detection of Pregnancy.
1. Classification Name
  Human Chorionic Gonadotropin (hCG) Test System.
Legally Marketed Devices to Which Substantial Equivalence is C. Claimed
- 1 . Quidel® QuickVue® One-Step hCG Urine Test (ref. K925435)
- 1. Wyntek Diagnostics OSOM™ hCG-Urine Test (ref. K953383)

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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.

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.

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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	ScrippsLaboratories hCGOne-Step	Quidel®QuickVue® One-Step hCG UrineTest	WyntekDiagnosticsOSOM™ hCG-Urine Test
Intended Use
Diagnostic Use	Early Detection ofPregnancy	Early Detection ofPregnancy	Early Detection ofPregnancy
Use Setting	Laboratory andProfessional	Laboratory andProfessional	Laboratory andProfessional
Methodology
Sample	Urine	Urine	Urine
Timing	5 minutes	3 minutes	1 minute
Format	One-Step	One-Step	One-Step
ResultsInterpretation	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	ChromatographicImmunoassay	ChromatographicImmunoassay	ChromatographicImmunoassay
Antibodies	Murine Monoclonaland CaprinePolyclonal Anti-hCG	Murine Monoclonaland CaprinePolyclonal Anti-hCG	Murine Monoclonaland RabbitPolyclonal 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%

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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
- 1. 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.

1. 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:

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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.

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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.

Regulation Number and Section

§ 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.