SCRIPPS LABORATORIES HCG ONE-STEP

K962906 · Scripps Laboratories, Inc. · JHI · Aug 23, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962906
• Device Name: SCRIPPS LABORATORIES HCG ONE-STEP
• Applicant: Scripps Laboratories, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Aug 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended 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.

Device Story

Device is a rapid, one-step chromatographic immunoassay dipstick for qualitative hCG detection in urine. Input: urine sample; Principle: lateral flow membrane-based assay using murine monoclonal and caprine polyclonal anti-hCG antibodies. If hCG concentration is ≥25 mIU/ml (WHO 3rd IS 75/537), two red bands appear; if absent, one red band appears. Used in laboratory and professional settings by trained personnel. Output: visual qualitative result (positive/negative). Result aids clinicians in pregnancy diagnosis. Benefits: rapid, early pregnancy detection.

Clinical Evidence

Multicenter field study of 507 urine specimens compared Scripps Laboratories hCG One-Step against Quidel QuickVue One-Step hCG Urine Test. Results: 100% sensitivity, 99.6% specificity, and 99.8% accuracy. Interference testing confirmed no cross-reactivity with common drugs, urine analytes, or hormones (LH, FSH, TSH) at specified concentrations. Performance unaffected by urine pH levels 4-9.

Technological Characteristics

Chromatographic immunoassay dipstick; membrane solid phase; murine monoclonal and caprine polyclonal anti-hCG antibodies; 25 mIU/ml detection limit; standardized to WHO 3rd IS 75/537; visual qualitative readout.

Indications for Use

Indicated for the qualitative detection of hCG in urine for early pregnancy diagnosis in professional and laboratory settings.

Regulatory Classification

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. 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.

Predicate Devices

• Quidel® QuickVue® One-Step hCG Urine Test (K925435)
• Wyntek Diagnostics OSOM™ hCG-Urine Test (K953383)

Submission Summary (Full Text)

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K962906

AUG 23 1986

Scripps Laboratories hCG One-Step

510(k) Notification

## SECTION VI.

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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SCRIPPS LABORATORIES

Scripps Laboratories hCG One-Step
510(k) Notification
Page VI-1

# VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## A. Submitter Identification

1. Name and Address
Scripps Laboratories, Inc.
6838 Flanders Drive
San Diego, CA 92121

2. Contact Person
Noreen E. Leamon

3. Phone Numbers
Voice: [phone]
FAX: [phone]

4. Date of Submission
July 22, 1996

## B. Names of Device

1. Proprietary Name
SCRIPPS LABORATORIES hCG One-Step

2. Common Name
A Rapid, One-Step Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Early Detection of Pregnancy.

3. Classification Name
Human Chorionic Gonadotropin (hCG) Test System.

## C. Legally Marketed Devices to Which Substantial Equivalence is Claimed

1. Quidel® QuickVue® One-Step hCG Urine Test (ref. K925435)

2. Wyntek Diagnostics OSOM™ hCG-Urine Test (ref. K953383)

6838 Flanders Drive, San Diego, CA 92121-2904 USA Telephone: [phone] FAX: [phone]

Primary Manufacturer of Diagnostic Biochemicals

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SCRIPPS LABORATORIES

Scripps Laboratories hCG One-Step 510(k) Notification Page VI-2

## VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

### 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® QuickVue® 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.

6838 Flanders Drive, San Diego, CA 92121-2904 USA Telephone: [phone] FAX: [phone]

Primary Manufacturer of Diagnostic Biochemicals

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SCRIPPS LABORATORIES

Scripps Laboratories hCG One-Step

510(k) Notification

Page VI-3

# VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

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% |
| | | | |

6838 Flanders Drive, San Diego, CA 92121-2904 USA Telephone: [phone] FAX: [phone]

Primary Manufacturer of Diagnostic Biochemicals

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SCRIPPS LABORATORIES

Scripps Laboratories hCG One-Step

510(k) Notification

Page VI-4

# VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

## 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® QuickVue® 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

| Scripps Laboratories
hCG One-Step | Comparative Test | * Sample contained 17.9
mIU/ml hCG |
| --- | --- | --- |
| + | 238 | 1* |
| - | 0 | 268 | |

### 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.

### 3. 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:

6838 Flanders Drive, San Diego, CA 92121-2904 USA Telephone: [phone] FAX: [phone]

Primary Manufacturer of Diagnostic Biochemicals

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SCRIPPS LABORATORIES

Scripps Laboratories hCG One-Step 510(k) Notification Page VI-5

## VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

G. Performance Data (continued)

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.

6838 Flanders Drive, San Diego, CA 92121-2904 USA Telephone: [phone] FAX: [phone]

Primary Manufacturer of Diagnostic Biochemicals

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SCRIPPS LABORATORIES

Scripps Laboratories hCG One-Step
510(k) Notification
Page VI-6

## VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

G. Performance Data (continued)

5. 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.

6838 Flanders Drive, San Diego, CA 92121-2904 USA Telephone: [phone] FAX: [phone]

Primary Manufacturer of Diagnostic Biochemicals