Who is the manufacturer of SPERM PREPARATION MEDIA?

Genx Intl., Inc. submitted the Traditional clearance for SPERM PREPARATION MEDIA (K962816).

What is the FDA product code for SPERM PREPARATION MEDIA?

MOL. It is classified under 21 CFR 884.5300 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for SPERM PREPARATION MEDIA?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SPERM PREPARATION MEDIA?

Irvine Sperm Capacitation Media (K861188).

SPERM PREPARATION MEDIA

K962816 · Genx Intl., Inc. · MOL · Nov 26, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K962816
Device Name	SPERM PREPARATION MEDIA
Applicant	Genx Intl., Inc.
Product Code	MOL · Obstetrics/Gynecology
Decision Date	Nov 26, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.5300
Device Class	Class 2

Intended Use

Sperm Preparation Media is a culture media used to prepare sperm prior to Intrauterine Insemination (IUI) procedures. The preparation of sperm includes washing of the sperm and its separation from the semen. This product as indicated in the label is For In Vitro Use Only.

Device Story

Sperm Preparation Media; culture medium for sperm processing; used prior to Intrauterine Insemination (IUI). Functions by washing sperm and separating it from semen. Ingredients include sterile water, minerals, glucose, and penicillin. Provided in sterile bottles. Used in clinical laboratory settings by trained personnel. Output is processed sperm sample ready for clinical insemination. Benefits include standardized preparation of sperm for fertility procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on chemical composition and intended use comparison to predicate.

Technological Characteristics

Mineral essential media; ingredients: sterile water, minerals, glucose, penicillin. Provided in sterile bottles. No software or electronic components.

Indications for Use

Indicated for use in the preparation of sperm prior to Intrauterine Insemination (IUI) procedures, specifically for washing and separating sperm from semen. For in vitro use only.

Regulatory Classification

Identification

A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.

Special Controls

*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.

Predicate Devices

Irvine Sperm Capacitation Media (K861188)

Related Devices

K241095 — ARTSMedia Semen Wash Medium · Artsmedia Denmark Aps · Dec 18, 2024
K991379 — QUINN'S SPERM WASHING MEDIUM · Advanced Reproductive Technologies · Feb 2, 2000
K212410 — VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium · Shenzhen Vitavitro Biotech Co., Ltd. · Feb 1, 2022
K023717 — SPERM WASH MEDIUM WITH GENTAMICIN · Conception Technologies · Dec 13, 2002
K192644 — GM501 SpermAir and GM501 SpermActive · Hamilton Thorne Incorporated · Apr 23, 2020

Submission Summary (Full Text)

{0} SMDA 510 (K) Summary -1- Prenarket Notification [K962816] K962816 1192 1) GENX International, Inc. 339 Bartlett Drive Madison, CT 06443 Tel: 203-421-8300 Fax: 203-421-8301 Contact Individual: Michael Cecchi Date: July 15, 1996 2) DEVICE NAME: Sperm Preparation Media Proprietary Name: GenX Sperm Preparation Media Common or Usual name: Culture Media Classification Name: Sperm Preparation Media According to the Classification Names for In Vitro Diagnostic Products (FDA 95-4246) we believe that this media belongs in one of the following classes: CULTURE MEDIA, NON PROPAGATING TRANSPORT 83JSM CULTURE MEDIA, GENERAL NUTRIENT BROTH 83JSC CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL 83JSG CULTURE MEDIA, SUPPLEMENT 83JSK > ~~"Cervical Cup" old procede prior to HQLprocede~~ 3) This product is substantially equivalent to the Irvine Sperm Capacitation Media (product code HDR and K861188). This product has the same intended use, the same original formula, and the same basic ingredients. 4) Sperm Preparation Media is a culture media used to prepare sperm prior to Intrauterine Insemination (IUI) procedures. The preparation of sperm includes washing of the sperm and its separation from the semen. The basic ingredients of this products as described in the Formulation section of the submission are sterile water, minerals, glucose, and penicillin. This product is provided in sterile bottles. This product as indicated in the label is For In Vitro Use Only. {1} K962F16 ρ2012 SMDA 510 (K) Summary - 2- Premarket Notification [K962816] 5) The intended use of this media is for *in vitro* use only, the same as the Irvine Sperm Capacitation Media (product code HDR and K861188). 6) Sperm Preparation Media has the same characteristics and the same chemical composition as the predicate device Irvine Sperm Capacitation Media (product code HDR and K861188). Sperm Preparation Media is a mineral essential media with glucose and penicillin, which are the same basic ingredients as the Irvine Sperm Capacitation Media.