Actim PROM

Basic Information

• Brand Name: Actim PROM
• Primary DI: 06430030990714
• Version / Model: 30821ETUS
• Company Name: Actim Oy
• Labeler DUNS: 368646046
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-28
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 7c9fad6a-4b68-4a70-9b02-8a929f7c9e57

Device Description

Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solution contains bovine serum albumin (BSA), protease inhibitors and preservatives. - One dipstick in a sealed aluminum foil pouch with desiccant. - One sterile polyester swab for specimen collection.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAM	Immunoassay, Insulin-Like Growth Factor Binding Protein-1	Clinical Chemistry	862.1550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64054	Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of insulin-like growth factor binding protein 1 (IGFBP-1) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the detection of foetal membrane rupture in pregnancy and/or to help predict the risk of preterm or imminent delivery. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	06430030990615	GS1	20 tests kit box	20	In Commercial Distribution
Primary	06430030990714	GS1
Package	06430030990608	GS1	10 tests kit box	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K123986	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius