Indicator Method, Protein Or Albumin (urinary, Non-quant.)

Device Code: 442

Product Code(s): JIR

Device Classification Information

• Device Type ID: 442
• Device Name: Indicator Method, Protein Or Albumin (urinary, Non-quant.)
• Regulation Description: Urinary Protein Or Albumin (nonquantitative) Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.1645 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JIR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 13-93 IEEE Std 11073-10422-2016
  Health Informatics - Personal Health Device Communication, Part 10422: Device Specialization - Urine Analyzer

Total Product Life Cycle

• Device Type ID: 442
• Device: Indicator Method, Protein Or Albumin (urinary, Non-quant.)
• Product Code: JIR
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Urinary Protein Or Albumin (nonquantitative) Test System.
• CFR Regulation Number: 862.1645 [🔎]

Premarket Reviews
Manufacturer	Decision
ACON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
False Negative Result	3
Incorrect Or Inadequate Test Results	2
False Positive Result	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	7

TPLC Last Update: 2019-04-02 19:34:43