MQK · Labware, Assisted Reproduction
Obstetrics/Gynecology · 21 CFR 884.6160 · Class 2
Overview
| Product Code | MQK |
|---|---|
| Device Name | Labware, Assisted Reproduction |
| Regulation | 21 CFR 884.6160 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.
Classification Rationale
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (20 of 50)
Showing 20 most recent of 50 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241626 | SperSort Sperm Sorting Chip (IPG02) | Ipreg Incorporation | Feb 20, 2025 | SESE |
| K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) | Guangzhou Hehong Biotech Co., Ltd. | Feb 3, 2025 | SESE |
| K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount Aps | Jan 31, 2025 | SESE |
| K241341 | cryo-GO Vitrification Device | Fujifilm Irvine Scientific | Sep 26, 2024 | SESE |
| K240002 | G-Vitri Vitrification Straw | Gimbo Medical Technology Shenzhen Co., Ltd. | Jun 14, 2024 | SESE |
| K232980 | SpermAlign Sperm Separation Device | Cytoswim, Ltd. | Mar 14, 2024 | SESE |
| K233177 | Nest VT Vitrification Device | Cook Incorporated | Mar 8, 2024 | SESE |
| K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device | Bonraybio Co., Ltd. | Oct 31, 2022 | SESE |
| K213869 | EmbryoSlide+ ic8 dish | Vitrolife A/S | Mar 11, 2022 | SESE |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | Allwin Medical Devices, Inc. | Jun 4, 2021 | SESE |
| K201213 | Pasteur Pipette 3mL, Pasteur Pipette 1mL | Hertart Aps | Dec 16, 2020 | SESE |
| K200815 | VitriGuard | Origio A/S | Jun 25, 2020 | SESE |
| K181461 | Rapid-i Kit | Vitrolife Sweden AB | Jan 4, 2019 | SESE |
| K181469 | Cryotop®US-flash and Cryotop®US-scoop | Kitazato Corporation | Nov 9, 2018 | SESE |
| K180740 | VitriGuard | Origio A/S | May 4, 2018 | SESE |
| K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) | Dxnow, Inc. | Mar 8, 2018 | SESE |
| K172751 | iVitri Straw | Reprobitech Corp. | Feb 9, 2018 | SESE |
| K162640 | iVitri EZ | Reprobitech Corp. | Jun 30, 2017 | SESE |
| K162833 | VitriGuard | Origio A/S | Feb 16, 2017 | SESE |
| K162051 | Cryotec | Reprolife, Inc. | Dec 14, 2016 | SESE |
Top Applicants
- Becton Dickinson Labware — 3 clearances
- Origio A/S — 3 clearances
- Vitrolife Sweden AB — 3 clearances
- <Genx> Intl., Inc. — 2 clearances
- Auxogyn, Inc. — 2 clearances
