HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

K041728 · Immunostics Inc., · JHI · Aug 11, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041728
• Device Name: HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
• Applicant: Immunostics Inc.,
• Product Code: JHI · Clinical Chemistry
• Decision Date: Aug 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The Immuno/hCG Detector Combi™ is for the rapid and qualitative determination of Human Chorionic Gonadotropin (hCG) in urine or serum. It is intended for professional and laboratory use only. The immuno/hCG Detector™-Urine is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine. It is intended for professional and laboratory use only. The Immuno/hCG Detector Stix™ is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine. It is intended for professional and laboratory use only.

Device Story

Lateral flow chromatographic immunoassay for qualitative hCG detection; utilizes mouse monoclonal and goat polyclonal antibodies. Input: 150 uL urine or serum sample. Operation: solid-phase sandwich immunoassay; visual interpretation of test lines. Output: qualitative positive/negative result. Used in clinical laboratories and physician’s office laboratories (POL) by professional staff. Provides rapid pregnancy status determination to assist clinical decision-making.

Clinical Evidence

Bench testing only. Method comparison study conducted at three physician office laboratories (POLs) using 141 urine and 120 serum samples for Combi, and 133 urine samples for Urine and Stix versions. Results showed 100% agreement with predicate devices. Analytical sensitivity established at 20 mIU/mL; specificity confirmed against hLH, hFSH, and hTSH; no interference from common substances.

Technological Characteristics

Lateral flow immunoassay for qualitative hCG detection. Form factors include urine test, stix, and combi formats. Professional/laboratory use only. No software or electronic components.

Indications for Use

Indicated for the rapid, qualitative detection of hCG in urine to aid in early pregnancy detection. Intended for professional and laboratory use only.

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.

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k041728

B. Purpose for Submission:
New device

C. Analyte:
Human Chorionic Gonadotropin (hCG)

D. Type of Test:
Qualitative

E. Applicant:
Immunostics, Inc.

F. Proprietary and Established Names:
hCG Detector Combi™
hCG Detector™ -Urine
hCG Detector Stix™

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1155 Human Chorionic Gonadotropin (hCG) test system
2. Classification:
Class II
3. Product Code:
JHI
4. Panel:
75

H. Intended Use:
1. Intended use(s):
The Immuno/hCG Detector Combi™ is for the rapid and qualitative determination of Human Chorionic Gonadotropin (hCG) in urine or serum. It is intended for professional and laboratory use only.
The immuno/hCG Detector™-Urine is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine. It is intended for professional and laboratory use only.

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The Immuno/hCG Detector Stix™ is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine. It is intended for professional and laboratory use only.

2. **Indication(s) for use:**
See above

3. **Special condition for use statement(s):**
This device is intended for clinical laboratory and physician’s office laboratory (POL) use.

4. **Special instrument Requirements:**
Not applicable

I. **Device Description:**
The immuno/hCG Detector has three separate formants: hCG Detector Combi™ (25 tests per box), hCG Detector™-Urine (25 tests per box) and hCG Detector Stix™ (50 tests per box). The hCG Detector Combi™ and the hCG Detector™-Urine both consists of one hCG Detector Cassette, a disposable specimen dropper in a foil pouch and instructions. The hCG Detector Stix™ test consists of one Immuno hCG Detector strip.

J. **Substantial Equivalence Information:**

1. **Predicate device name(s):**
UniMark hCG Combo
UniStep hCG Pregnancy Test
ACON One Step Pregnancy Strip

2. **Predicate K number(s):**
Unimark hCG Combo K01394
UniStep hCG Pregnancy Test K941090
ACON One Step Pregnancy Strip K993203

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3. Comparison with predicate:

Immuno/hCG Detector Combi™

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The Immuno/hCG Detector Combi™ is for the rapid and qualitative determination of Human Chorionic Gonadotropin (hCG) in urine or serum. It is intended for professional and laboratory use only. | The UniMark® hCG Combo Pregnancy Test Device is for the rapid and qualitative determination of Human Chorionic Gonadotropin (hCG) in urine or serum. It is intended for professional and laboratory use only. |
| Matrix | Urine or Serum | Urine or Serum |
| Sample Size | 150 uL | 150 uL |
| Principle/Methodology | Lateral Flow Chromatographic Immunoassay | Lateral Flow Chromatographic Immunoassay |
| | Mouse monoclonal and Goat polyclonal antibodies | Mouse monoclonal and Goat polyclonal antibodies |
| | | |
| Item | Device | Predicate |
| Detection Level | 20 mIU/mL | 25 mIU/mL |
| Test Time | 5 minutes for Urine
5 minutes for Serum | 5 minutes for Urine
7 minutes of Serum |

Immuno/ hCG Detector™-Urine

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The Immuno/hCG Detector™-Urine is for the rapid and qualitative determination of Human Chorionic Gonadotropin (hCG) in urine. It is intended for professional and laboratory use only. | The UniMark® hCG Pregnancy Test Device is for the rapid and qualitative determination of Human Chorionic Gonadotropin (hCG) in urine. It is intended for professional and laboratory use only. |
| Matrix | Urine | Urine |
| Sample Size | 150 uL | 150 uL |
| Principle/Methodology | Lateral Flow Chromatographic Immunoassay | Lateral Flow Chromatographic Immunoassay |
| | Mouse monoclonal and Goat polyclonal antibodies | Mouse monoclonal and Goat polyclonal antibodies |

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| Item | Device | Predicate |
| --- | --- | --- |
| Detection Level | 20 mIU/mL | 25 mIU/mL |
| Test Time | 5 minutes for Urine | 5 minutes for Urine |

## Immuno/ hCG Detector Stix™

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The Immuno/hCG Detector Stix™ is for the rapid and qualitative determination of Human Chorionic Gonadotropin (hCG) in urine. It is intended for professional and laboratory use only. | The UniMark® hCG Pregnancy Test Device is for the rapid and qualitative determination of Human Chorionic Gonadotropin (hCG) in urine. It is intended for professional and laboratory use only. |
| Matrix | Urine | Urine |
| Sample Size | 150 uL | 150 uL |
| Principle/Methodology | Lateral Flow Chromatographic Immunoassay | Lateral Flow Chromatographic Immunoassay |
| | Mouse monoclonal and Goat polyclonal antibodies | Mouse monoclonal and Goat polyclonal antibodies |
| | | |
| Item | Device | Predicate |
| Detection Level | 20 mIU/mL | 25 mIU/mL |
| Test Time | 5 minutes for Urine | 5 minutes for Urine |

## K. Standard/Guidance Document Referenced (if applicable):

1) Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices, CDRH Guidance Document Nov.6, 1996

2) ISO13485:996 First Edition 1996-12-15 Quality Systems-Medical Devices with Particular Requirements for Application of ISO 9001, Second Addition 1994-07-01, the International Organization for Standards.

## L. Test Principle:

This device is a solid phase, sandwiched chromatographic immunoassay.

## M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
See Below
b. Linearity/assay reportable range:

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Not Applicable

c. Traceability (controls, calibrators, or method):
All three detectors were calibrated with WHO 3rd I.S.

d. Detection limit:
The sensitivity of all three devices is 20 mIU/mL in serum or urine.

Immuno/ hCG Detector Combi™
20 urine and 20 serum clinical samples obtained from normal (non-pregnant) individuals were spiked with hCG to the concentrations of 5, 15, 20, 25, 50 mIU/mL and were tested. hCG levels in serum and urine that were greater than or equal to 15 mIU/mL was positive 100% of the time. hCG levels in serum and urine of 0 and 5 mIU/mL were negative 100% of the time.

Immuno/ hCG Detector™-Urine
20 urine clinical samples obtained from normal (non-pregnant) individuals were spiked with hCG to the concentrations of 5, 15, 20, 25, 50 mIU/mL and were tested. hCG levels urine that were greater than or equal to 15 mIU/mL was positive 100% of the time. hCG levels in urine of 0 and 5 mIU/mL were negative 100% of the time.

Immuno/ hCG Detector Stix™-Urine
20 urine clinical samples obtained from normal (non-pregnant) individuals were spiked with hCG to the concentrations of 5, 15, 20, 25, 50 mIU/mL and were tested. hCG levels urine that were greater than or equal to 15 mIU/mL was positive 100% of the time. hCG levels in urine of 0 and 5 mIU/mL were negative 100% of the time.

e. Analytical specificity:
All three devices were tested and were found non-reactive in specimens spiked with Luteinizing Hormone (hLH at 300mIU/mL), Follicle Simulating Hormone (hFSH at 1000 mIU/mL) and Thyroid Stimulating Hormone (hTSH at 1000 uIU/mL). Commonly found substances (Prescription, OTC, chemical and biological analytes) were spiked into specimens containing 0, 20 and 100 mIU/mL hCG and did not effect the test results.

f. Assay cut-off:
20 mIU/mL for all three devices

2. Comparison studies:
a. Method comparison with predicate device:
All three devices were tested and compared to the Biotech Atlantics UniMark Device predicate at three POLs (physicians office laboratories). See the chart below. The device was compared to the

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predicate and the results are shown in the chart below. The urine samples were selected and supplied by the POLs through routine pre-screened test material from women of childbearing age. The serum samples were supplied as coded samples consisting of 20 negatives and 20 positives, with 8/20 positives within + 20% of the cutoff value of 20 mIU/mL.

| Device | # of Samples Tested | Matrix | # of positive results | # of Negative results | % Agreement to predicate |
| --- | --- | --- | --- | --- | --- |
| Immuno/ hCG Detector Combi™ | 141 | Urine | 65 | 76 | 100 |
| Immuno/ hCG Detector Combi™ | 120 | Serum | 59 | 61 | 100 |
| Immuno/ hCG Detector ™ -Urine | 133 | Urine | 62 | 71 | 100 |
| Immuno/ hCG Detector Stix™-Urine | 133 | Urine | 61 | 72 | 100 |

b. Matrix comparison: Not applicable

3. Clinical studies:
a. Clinical sensitivity: Not applicable
b. Clinical specificity: Not applicable
c. Other clinical supportive data (when a and b are not applicable): Not applicable

4. Clinical cut-off: See detection limit above.

5. Expected values/Reference range: Expected values were established in the literature.

N. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.