Instant-View Pregnancy Test – hCG Rapid Midstream Test – OTC (2 Tests/Kit)
$6.00
FDA 510(k) Cleared
CLIA Waived
2 Tests per Kit
2 tests per kit • $3.00 per test
The Instant-View® Pregnancy Test is an over-the-counter midstream urine test for the qualitative detection of human chorionic gonadotropin (hCG) as an aid in the early detection of pregnancy. The test has a sensitivity of 25 mIU/mL and can be used as early as the first day of a missed period.
- Easy-to-use midstream format for home testing
- 25 mIU/mL hCG sensitivity
- Read the result at 5 minutes; do not read after 10 minutes
- Greater than 99% agreement in the manufacturer’s laboratory comparison study
- Two single-use test devices per kit
| 1-5 | 6-10 | 11+ |
| $6.00 | $5.52 | $5.22 |
Instant-View Pregnancy Test Overview
The Instant-View® Pregnancy Test is an FDA 510(k)-cleared over-the-counter midstream test for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended as an aid in the early detection of pregnancy and may be used as early as the first day of a missed period.
This two-test kit uses a simple one-step format with a 25 mIU/mL hCG sensitivity. The test may be performed at any time of day, although avoiding excessive liquids before testing can reduce the chance of diluting the urine specimen.
FDA 510(k) Cleared
CLIA Waived
2 Tests per Kit
Features and Benefits
Over-the-counter midstream pregnancy test designed for convenient home use
Qualitatively detects hCG in urine at a sensitivity of 25 mIU/mL
Can be used as early as the first day of a missed period
Read the result at 5 minutes; strong positive results may appear sooner
Built-in control line helps confirm that the test was performed correctly
May be used directly in the urine stream or dipped into urine collected in a clean container
Room-temperature storage with no refrigeration required
Includes two single-use test devices per kit
Product Details
02-2480-2
DTK-101252
2 Tests
K984075
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Qualitative lateral-flow immunoassay |
| Analyte | Human chorionic gonadotropin (hCG) |
| Specimen | Human urine |
| Format | Midstream test device |
| Sensitivity | 25 mIU/mL |
| Application time | Approximately 10 seconds in the urine stream or collected urine |
| Result time | Read at 5 minutes; strong positive results may appear in 1-3 minutes; do not read after 10 minutes |
| Regulatory status | FDA 510(k) cleared for over-the-counter use; CLIA waived |
| Storage | 59-86°F (15-30°C); do not freeze or expose above 86°F (30°C) |
| Stability | At least 2 years or until the expiration date printed on the label, whichever comes first |
| Package size | 2 single-use test devices per kit |
How to Perform the Test
Open the pouch: Remove a test device from the foil pouch and take off the cap immediately before testing.
Apply urine for about 10 seconds: Hold the thumb grip and place the absorbent wick in the urine stream. Alternatively, dip at least four-fifths of the wick into urine collected in a clean container without wetting the plastic body.
Recap and lay flat: Replace the cap and place the test device on a clean, flat surface with the result window facing upward.
Read at 5 minutes: Strong positive results may appear in 1-3 minutes, but weak positive results can require the full 5 minutes. Do not interpret the test after 10 minutes and do not reuse the device.
This summary does not replace the package insert. Read the complete instructions supplied with the product before performing or interpreting the test.
Understanding the Results
| Result | Line Pattern | Meaning |
|---|---|---|
| Positive | Both the control line (C) and test line (T) are visible. A faint T line is still positive. | hCG was detected, indicating that you may be pregnant. Contact a healthcare professional for appropriate follow-up. |
| Negative | Only the control line (C) is visible. | hCG was not detected at or above the test’s sensitivity. If pregnancy is still suspected, repeat the test in 1-3 days using fresh urine. |
| Invalid | No control line appears, whether or not a test line is visible. | Review the procedure and repeat the test with a new device. |
Performance Information
Greater than 99% laboratory comparison agreement: The package insert reports greater than 99% accuracy by comparison with another commercially available pregnancy test in a laboratory study.
Consumer usability study: The package insert states that more than 99% of participating women were able to follow the instructions and obtain results confirmed by professionals.
Greater than 99% describes results from the manufacturer’s comparison and usability studies. Individual results depend on testing at an appropriate time, following the instructions, avoiding excessive urine dilution and interpreting the result within the required time window.
Important Testing Considerations
- The test may be performed at any time of day, but avoid drinking large amounts of liquid for at least 30 minutes beforehand because diluted urine can produce a false-negative result.
- Testing too early may produce a negative result even when pregnancy is present. Repeat with a new device in 1-3 days if pregnancy is still suspected.
- Medications containing hCG may cause a false-positive result. Tell your healthcare professional about medications you are taking.
- hCG may remain detectable for several weeks after delivery or pregnancy loss and may also be associated with certain conditions other than a normal pregnancy.
- A urine hCG test cannot distinguish an ectopic pregnancy from a normal pregnancy.
- The test result must be considered together with other clinical information before pregnancy is diagnosed.
Storage and Handling
Store the kit at 59-86°F (15-30°C)
Do not freeze or expose the kit to temperatures above 86°F (30°C)
Do not use a device if the foil pouch is damaged or the device has been exposed to air for more than 30 minutes
Do not use after the expiration date printed on the product label
Instructions and Product Documents
Frequently Asked Questions
What does the Instant-View Pregnancy Test detect?
It qualitatively detects human chorionic gonadotropin, or hCG, in urine as an aid in the early detection of pregnancy.
Is this an over-the-counter home pregnancy test?
Yes. The Instant-View Pregnancy Urine Mid-Stream Test is FDA 510(k) cleared under K984075 for over-the-counter use.
When can I use the test?
The package insert states that the test may detect hCG as early as the first day of a missed period. Testing too early can produce a false-negative result, so repeat the test in 1-3 days if pregnancy is still suspected.
When should I read the result?
Read the result at 5 minutes. Strong positive results may appear in 1-3 minutes, but weak positive results can require the full 5 minutes. Do not read after 10 minutes.
Is a faint test line positive?
Yes. A visible control line and any visible test line, including a faint test line, are interpreted as a positive result according to this product’s package insert.
Can I perform the test at any time of day?
Yes. The insert allows testing at any time of day. Avoid drinking large amounts of liquid for at least 30 minutes before testing because diluted urine may affect the result.
What should I do if the result is negative but I still think I am pregnant?
Repeat the test with a new device in 1-3 days using fresh urine. If you continue to receive unexpected results, contact a healthcare professional.
How many tests are included?
This configuration includes two single-use Instant-View Pregnancy Test devices.
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Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 8 × 5 × 3 in |
