ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
Device Facts
| Record ID | K032987 |
|---|---|
| Device Name | ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 |
| Applicant | Unotech Diagnostics, Inc. |
| Product Code | JHI · Clinical Chemistry |
| Decision Date | Nov 17, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
Indications for Use
The intended use of the Unotech Accutest and Accustrip hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.
Device Story
Immunochromatographic test for qualitative hCG detection in urine or serum; utilizes mouse anti-beta hCG monoclonal antibody-colloidal gold conjugate. Sample application via dipstick (AccuStrip) or cassette sample well (AccuTest). HCG-antibody-gold complex migrates to immobilized goat anti-alpha hCG capture region and goat anti-mouse IgG control region. Positive result indicated by two colored bands at 25 mIU/mL hCG; negative result indicated by single control band. Used in clinical settings; operated by healthcare professionals. Provides rapid visual confirmation of pregnancy status to aid clinical decision-making.
Clinical Evidence
Comparative study of 181 specimens (94 urine, 87 serum) from patients seeking pregnancy confirmation. Subject devices compared against Quidel QuickVue hCG Combo Test. Results showed 100% agreement. Sensitivity verified using spiked samples at 0, 25, 50, 104, 5x10^5, and 10^6 mIU/mL; 100% detection at 25 mIU/mL and above.
Technological Characteristics
Lateral flow immunoassay test system. Qualitative detection of hCG. Compatible with human urine or serum. Sensitivity range: 25 mIU/mL to 1,000,000 mIU/mL.
Indications for Use
Indicated for the qualitative determination of hCG in human urine or serum for the early detection of pregnancy in patients seeking confirmation of pregnancy.
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 hCG Combo Test
Related Devices
- K981838 — ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 · Unotech Diagnostics, Inc. · Jun 25, 1998
- K974060 — MINISTRIP/ SERUM AND URINE COMBO HCG TEST · International Newtech Development, Inc. · Apr 9, 1998
- K993065 — ACON COMBO PREGNANCY · ACON Laboratories, Inc. · Oct 8, 1999
- K031048 — CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST · Access Bio Incorporate · Jun 16, 2003
- K981165 — AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST · Germaine Laboratories, Inc. · Apr 16, 1998
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
K032987
B. Analyte:
Human Chorionic Gonadotropin (HCG)
C. Type of Test:
Immunoassay for the qualitative measurement of HCG in serum or urine
D. Applicant:
Unotech Diagnostics, Inc.
E. Proprietary and Established Names:
AccuTest™ hCG-Combo
AccuStrip™ hCG-Combo
F. Regulatory Information:
1. Regulation section:
21 CFR §862.1155
2. Classification:
Class II
3. Product Code:
JHI
4. Panel:
Clinical Chemistry
G. Intended Use:
1. Indication(s) for use:
The intended use of the Unotech Accutest and Accustrip hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.
2. Special condition for use statement(s):
Prescription Use Only
3. Special instrument Requirements:
N/A
H. Device Description:
The AccuTest™ hCG-Combo device consists of a test strip enclosed in a plastic cassette, while the AccuStrip™ hCG-Combo device consists of a test strip only. The AccuTest has a sample well at one end, and both devices have a control region and a test region.
I. Substantial Equivalence Information:
1. Predicate device name(s):
Quidel QuickVue hCG Combo Test
2. Predicate K number(s):
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K 932042
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Devices | Predicate |
| Intended Use | Same | Simple, rapid immunoassay for the detection of hCG in serum or urine for the early detection of pregnancy |
| Matrix | Same | Serum, Urine |
| Methodology | Same | Immunochromatographic |
| Specificity | No cross-reactivity with: LH @ 300 mIU/mL FSH @ 1000 mIU/mL TSH @ 1000 mIU/mL | No cross-reactivity with: LH @ 500 mIU/mL FSH @ 1000 mIU/mL TSH @ 1000 mIU/mL |
| Accuracy | Same | >99% agreement |
| Antibodies | Same | Goat, mouse |
| Standardization | WHO 3rdIS 75/537 | WHO 4thIS 75/589 |
| Physical Characteristics | Test strip only (Accu-Strip)Test strip housed in a plastic cartridge (Accu-Test) | Test strip housed in a plastic cartridge with a result window and a sample well |
| Test Read Times | Same | Urine: 3 minutes Serum: 5 minutes |
| Sensitivity/Detection Limit | Same | 25 mIU/mL |
| Endpoint/Interpretation | Same | Test and control lines appear for a positive result. Control line only appears for a negative result. Absence of a control line indicates an invalid test. |
| Differences | | |
| Item | Device | Predicate |
| Sample Volume/Application | Test strip is dipped into urine or serum (Accu-Strip)Approximately 135 μL or 3 drops are added to the sample well with the supplied dropper (Accu-Test) | Approximately 125 μL or 3 drops are added to the sample well with the supplied dropper |
| Device Storage | 2-30°C | 15-30°C |
J. Standard/Guidance Document Referenced (if applicable):
None referenced
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## K. Test Principle:
**Accu-Test**: The test principle is immunochromatographic: using the supplied transfer pipette, 3 drops of urine or serum are applied to the strip through the sample well at one end. The urine mobilizes the mouse anti-β hCG monoclonal antibody-colloidal gold conjugate. HCG, if present in the sample, binds to the antibody-colloidal gold conjugate. The sample, antibody-gold conjugate and the hCG-antibody-gold complex migrate through the immobilized goat anti-α hCG capture antibody region and then to an immobilized goat anti-mouse IgG region. If hCG is present at 25 mIU/mL or greater, two colored bands will appear to indicate a positive result. If hCG is absent, only one band (in the control region) will appear to indicate a negative result.
**AccuStrip**: The test principle is immunochromatographic: in the procedure, the strip is dipped into the urine or serum. The urine or serum mobilizes the mouse anti-β hCG monoclonal antibody-colloidal gold conjugate. HCG, if present in the sample, binds to the antibody-colloidal gold conjugate. The sample, antibody-gold conjugate and the hCG-antibody-gold complex migrate through the immobilized goat anti-α hCG capture antibody region and then to an immobilized goat anti-mouse IgG region. If hCG is present at 25 mIU/mL or greater, two colored bands will appear to indicate a positive result. If hCG is absent, only one band (in the control region) will appear to indicate a negative result.
## L. Performance Characteristics (if/when applicable):
1. **Analytical performance**:
a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A
c. Traceability (controls, calibrators, or method): WHO Third International Standard, 75/537
d. Detection limit: 25 mIU/mL
e. Analytical specificity:
The following compounds were added to urine and serum specimens at hCG concentrations of 0 and 25 mIU/mL. At the concentrations below there was no deviation from the expected results.
| Substances added | in Urine | in Serum |
| --- | --- | --- |
| Acetaminophen | 20 mg/dL | 20 mg/dL |
| Acetylsalicylic acid | 20 mg/dL | 20 mg/dL |
| Ampicillin | 20 mg/dL | 20 mg/dL |
| Ascorbic acid | 20 mg/dL | 20 mg/dL |
| Atropine | 20 mg/dL | 20 mg/dL |
| Bilirubin | 2 mg/dL | 2 mg/dL |
| Caffeine | 20 mg/dL | 20 mg/dL |
| Estradiol | 25 ng/mL | 25 ng/mL |
| Estriol | 25 ng/mL | 25 ng/mL |
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| Ethanol | 200 mg/dL | 200 mg/dL |
| --- | --- | --- |
| Gentisic acid | 20 mg/dL | 20 mg/dL |
| Glucose | 2,000 mg/dL | 2,000 mg/dL |
| Hemoglobin | 25 mg/dL | 250 mg/dL |
| Human serum albumin | 2,000 mg/dL | 2,000 mg/dL |
| Phenothiazine | 2 mg/dL | 2 mg/dL |
| Progesterone | 40 ng/dL | 40 ng/dL |
| Tetracycline | 20 mg/dL | 20 mg/dL |
| Triglycerides | — | 1,000 mg/dL |
| Urine pH | 5-9 | |
a. Assay cut-off:
See detection limit above
2. Comparison studies:
a. Method comparison with predicate device:
A total of 181 specimens (94 urine specimens and 87 serum specimens) from patients seeking confirmation of pregnancy were tested simultaneously with AccuTest™ hCG-Combo, AccuStrip™ hCG-Combo and the predicate. Test results show that both Unotech’s AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo have 100% agreement with the predicate. Results were as follows.
| | Unotech
AccuTest™ hCG-Combo | Unotech
AccuStrip™ hCG-Combo | Quidel
QuickVue hCG Combo |
| --- | --- | --- | --- |
| Positive (Urine) | 48 | 48 | 48 |
| Negative (Urine) | 46 | 46 | 46 |
| Positive (Serum) | 42 | 42 | 42 |
| Negative (Serum) | 45 | 45 | 45 |
b. Matrix comparison:
N/A
3. Clinical studies:
a. Clinical sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):
4. Clinical cut-off:
See detection limit above
5. Expected values/Reference range:
Human Chorionic Gonadotropin is not found in healthy males or healthy non-pregnant females in concentrations that can be detected by the Unotech AccuTest™ hCG-Combo or AccuStrip™ hCG-Combo
M. Conclusion:
Based upon the information provided for the file, I recommend that the Unotech AccuTest™ hCG-Combo and AccuStrip™ hCG-Combo are substantially equivalent to the predicate device.
