Mid-Stream Collection Kit
The Mid-Stream Collection Kit is a general hospital convenience kit containing the specimen container, cleansing wipes, and instructions needed for patients to collect a mid-stream clean-catch urine sample for urinalysis or microbiological culture to diagnose urinary tract infections and other conditions. Product code PWZ is established as a convenience kit under FDA's 1997 Convenience Kits Interim Regulatory Guidance and is under enforcement discretion, not requiring a 510(k) if all guidance criteria are met. It is classified as FDA Class I under regulation 21 CFR 880.6730, subject only to general controls. It falls under the General Hospital medical specialty and is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- PWZ
- Device Class
- FDA class 1
- Regulation Number
- 880.6730
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.