ACRO HCG Pregnancy Rapid Test
FDA 510(k) K172512 · Acro Biotech, Inc.
510(k) numberK172512
Submission
- Device name
- ACRO HCG Pregnancy Rapid Test
- Applicant
- Acro Biotech, Inc.
Rancho Cucamonga, CA, US - Received
- August 21, 2017
- Decision date
- February 2, 2018
- 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 |
|---|---|---|
| K180771 | Acro HCG Pregnancy Rapid TestLCX · Traditional | 05/18/2018SE |
| K060355 | Acro Biotech LLC Rapid Mdma Urine Test, Catalog MDMA0010000DJC · Traditional | 08/07/2006SE |
| K060354 | Acro Biotech LLC Rapid Benzodiazepine Urine Test, Catalog BZD001000JXM · Traditional | 07/28/2006SE |
| K053037 | Acro Biotech LLC Rapid Opiates Urine Test; Catalog# OPI00100DJG · Traditional | 06/15/2006SE |
| K053034 | Acro Biotech LLC Rapid Tetrahydrocannabinol Urine Test; Catalog# OPI001000LDJ · Traditional | 06/06/2006SE |
| K053033 | Acro Biotech LLC Rapid Methamphetamine Urine Test; Catalog# MET001000DJC · Traditional | 06/06/2006SE |
| K053035 | Acro Biotech LLC Rapid Benzoylecgonine Urine Test; Catalog# MET001000DIO · Traditional | 05/05/2006SE |
| K060353 | Acro Rapid Phencyclidine Urine Test, Catalog PCP001000LCM · Traditional | 05/03/2006SE |
| K053032 | Acro Biotech LLC Rapid Amphetamine Urine Test; Catalog# AMP001000DKZ · Traditional | 02/09/2006SE |
Questions and answers
When was ACRO HCG Pregnancy Rapid Test cleared by the FDA?
ACRO HCG Pregnancy Rapid Test (K172512) received a 510(k) decision of Substantially Equivalent on February 2, 2018, 165 days after the submission was received.
What is the product code of K172512?
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.