# K172257: TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)

- Pathway: 510(k) (Traditional)
- Applicant: True Diagnostics, Inc.
- Decided: Dec 22, 2017 after 149 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K992232 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123436: First Response Early Result Pregnancy Test, Church & Dwight Co., Inc. (2013) Summary page 8.

## Indications for use
TrueDx™ hCG Early Result Pregnancy Test (Midstream & Cassette Format) is rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative result: Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test against a few days after you missed period. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor. All results should be confirmed by your healthcare provider, especially when making decision about future medical care. VeriClear™ Early Result Pregnancy Test (Midstream & Cassette Format) is rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative result: Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test against a few days after you missed period. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor. All results should be confirmed by your healthcare provider, especially when making decision about future medical care.

Source page: https://510kreport.com/device/K172257
Methodology: https://510kreport.com/methodology