SBP: Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
FDA product code SBP. Class II, classified under 21 CFR 866.3171. What the classification flags say about Part 820 under the QMSR.
As of Nov 2, 2026, FDA product code SBP (Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test) is Class II under 21 CFR 866.3171, reviewed through 510(k), with 1 linked 510(k), De Novo or BK number, 0 PMAs and 0 recall product records.
Classification
- Product code
- SBP
- Device name
- Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
- Device class
- Class II
- Regulation
- 21 CFR 866.3171
- Review panel
- Microbiology
- Premarket route
- 510(k)
- CGMP-exempt flag
- No
- Life-sustaining flag
- No
- Implant flag
- No
- Third-party review
- Not a candidate
- Summary malfunction reporting
- Ineligible
FDA definition. A simple point-of-care nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) test is an in vitro diagnostic device that is intended for prescription use for the detection of HCV RNA in clinical specimens as an aid in the diagnosis of HCV infection or as an aid in the management of HCV-infected patients, including individuals without antibodies to HCV. This device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The test is not intended for use as a donor screening test for the presence of HCV RNA in blood, blood products, or tissue donors.
Data from openFDA as of 2 November 2026. Read the record on openFDA · FDA product code classification database
Part 820 requirements the flags point to
Part 820 rules for SBP
- CGMP exemptionClassification regulation, 21 CFR parts 862 to 892
- Not flaggedFDA does not flag this product code as exempt.A manufacturer of a finished device of this type falls under part 820 (21 CFR 820.1(a)). Some classification regulations exempt only part of a generic device type, so read the regulation for your device.FDA: QMSR, CGMP exemptions · 21 CFR 820.35
- Design and development, ISO 13485 clause 7.321 CFR 820.10(c)
- Rule names this classRule names Class II.21 CFR 820.10(c) requires manufacturers of class II and class III devices to comply with clause 7.3 and its subclauses.21 CFR 820.10
- Traceability, ISO 13485 clause 7.5.9.221 CFR 820.10(d)
- Not flaggedFDA does not flag this code as life-supporting or life-sustaining.820.10(d) is not indicated by this flag.21 CFR 820.10 · 21 CFR 860.3 · QMSR final rule, comment 49
- Complaint and record content21 CFR 820.35
- Rule names this classApplies to every finished-device manufacturer, exempt or not.820.35 adds content to complaint records, servicing records and UDI recording on top of ISO 13485 clause 4.2.5. FDA says CGMP exemption does not lift these records.21 CFR 820.35 · FDA: QMSR, CGMP exemptions
These flags describe the classification of a product code. They are not a determination for a specific device or manufacturer. How a manufacturer meets 21 CFR 820.10 depends on its own device, its intended use and the full text of the rule.
Clearances and recalls on record
- 510(k), De Novo and BK numbers linked
- 1 · Search these clearances
- PMA numbers linked
- 0
- Recall product records
- 0
- Adverse event reports
- Search MAUDE for SBP
Recall records count products, and one recall event can add many. Counts show activity in a category. They do not measure its safety.
Search all 7,098 product codes, or read the guide to the Part 820 rules behind these flags.
Check your quality documents against Part 820
Arca puts your SOPs and design files in a library and compares them against the Part 820 requirements for your device in a grid, one row per document and one column per requirement, with each cell cited to its source.