Inverness Medical Early Pregnancy Test
FDA 510(k) K002049 · Selfcare, Inc.
510(k) numberK002049
Submission
- Device name
- Inverness Medical Early Pregnancy Test
- Applicant
- Selfcare, Inc.
Waltham, MA, US - Received
- July 3, 2000
- Decision date
- July 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 09/09/2025SE |
| K251053 | Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 07/15/2025SE |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional | Assure Tech., LLC | 02/13/2025SE |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene…LCX · Traditional | Nanjing Synthgene Medical Technology Co., Ltd. | 01/31/2025SE |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional | Assure Tech., LLC | 01/15/2025SE |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX · Traditional | Andon Health Co, Ltd. | 12/20/2024SE |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…LCX · Traditional | Anhui Deepblue Medical Technology Co., Ltd. | 10/11/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 08/13/2024SE |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 06/21/2024SE |
| K232715 | Distinct® Digital Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 05/31/2024SE |
More from ACON Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002867 | Inverness Medical Ovulation Predictor TestCEP · Special | 10/12/2000SE |
| K002134 | One Touch Ultra Blood Glucose Monitoring SystemCGA · Special | 08/07/2000SE |
| K001427 | Modification to Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 06/02/2000SE |
| K000583 | Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 03/17/2000SE |
| K993632 | Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 11/12/1999SE |
| K991480 | Excel GE Blood Glucose Test Strips & Code StripCGA · Traditional | 09/17/1999SE |
| K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation…CEP · Traditional | 05/25/1999SE |
| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | 05/25/1999SE |
| K990939 | Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 04/20/1999SE |
| K983468 | Fasttake Adapter, Model # P/N 020-072-01JQP · Traditional | 12/17/1998SE |
Questions and answers
When was Inverness Medical Early Pregnancy Test cleared by the FDA?
Inverness Medical Early Pregnancy Test (K002049) received a 510(k) decision of Substantially Equivalent on July 27, 2000, 24 days after the submission was received.
What is the product code of K002049?
The FDA product code is LCX – Kit, Test, Pregnancy, Hcg, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1155.