Product Classification

• Device: amniotic fluid protein immunoassay
• Regulation Description: Urinary pH (nonquantitative) test system.
• Definition: To detect specified amniotic fluid proteins in cervicovaginal samples
• Physical State: dipstick or cassette
• Technical Method: Detects specified amniotic fluid proteins
• Target Area: Cervicovaginal fluid samples
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: PDS
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1550
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc