Quikresponse One Step Midstream Early Pregrancy Test
FDA 510(k) K112449 · Tianjin New Bay Bioresearch Co., Ltd.
510(k) numberK112449
Submission
- Device name
- Quikresponse One Step Midstream Early Pregrancy Test
- Applicant
- Tianjin New Bay Bioresearch Co., Ltd.
Yorba Linda, CA, US - Received
- August 25, 2011
- Decision date
- September 24, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K130275 | Quikscreen Multi (Mdma and Opi) OTC Drug Cup TestDJG · Traditional | 09/26/2013SE |
| K122064 | Forsure One Step Buprenorphine Cup Test DeviceDJG · Traditional | 05/07/2013SE |
| K071489 | Homecheck Multiple Drug Cup TestDKZ · Traditional | 03/28/2008SE |
| K073431 | Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use)…KHE · Special | 01/14/2008SE |
| K061617 | Forsure One Step Dip & Read (X) Drug Screen TestDKZ · Traditional | 11/22/2006SE |
| K052520 | Rapid Forsure One Step Multiple Drug (Up to 6) Screen Test Device for Amphetamine…DJG · Traditional | 04/24/2006SE |
| K052882 | Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test Cup DeviceDKZ · Traditional | 02/15/2006SE |
| K052208 | Glucose PilotNBW · Traditional | 12/09/2005SE |
| K042988 | Rapid One Step Buprenorphine Test CardDJG · Traditional | 05/12/2005SE |
| K042990 | For Sure One Step Buprenorphine Test StripDJG · Traditional | 05/10/2005SE |
Questions and answers
When was Quikresponse One Step Midstream Early Pregrancy Test cleared by the FDA?
Quikresponse One Step Midstream Early Pregrancy Test (K112449) received a 510(k) decision of Substantially Equivalent on September 24, 2012, 396 days after the submission was received.
What is the product code of K112449?
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.