V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
FDA 510(k) K192931 · Helena Laboratories, Corp.
510(k) numberK192931
Submission
- Device name
- V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
- Applicant
- Helena Laboratories, Corp.
Beaumont, TX, US - Received
- October 17, 2019
- Decision date
- April 19, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKA – Abnormal Hemoglobin Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7415
- Specialty
- Hematology
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| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA · Traditional | Sebia | 04/04/2024SE |
| K222635 | Premier Resolution SystemGKA · Traditional | Trinity Biotech (Primus Corporation, Dba Trinity… | 08/04/2023SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | Sebia | 12/14/2018SE |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA · Special | Bio-Rad Laboratories, Inc. | 09/13/2017SE |
| K112550 | Capillarys Hemoglobin, Capillarys Flex Piercing SystemGKA · Traditional | Sebia | 05/25/2012SE |
| K112491 | Sebia Capillarys Hemoglobin(E) with Capillarys 2GKA · Traditional | Sebia | 05/24/2012SE |
| K091283 | Capillarys Neonat HB (PN 2006)GKA · Traditional | Sebia | 02/22/2010SE |
| K082227 | Minicap Hemoglobin(E) Kit, Model 2207, 2227GKA · Traditional | Sebia | 03/26/2009SE |
| K080911 | Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and…GKA · Special | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 05/02/2008SE |
| K052291 | Capillary's Hemoglobin(E) (PN 2007)GKA · Traditional | Sebia | 06/27/2006SE |
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| K061069 | Spife IFE-15 Pentavalent, Model 3456, Spife IFE-9 Pentavalent Kit, Model 3457, Spift…CFF · Traditional | 07/06/2006SE |
| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
| K050053 | Hemoram/Aggram AnalyzerJPA · Traditional | 07/11/2005SE |
| K024162 | Spife 3000 Titan Gel Igg Ief Kit, Model 3389CFF · Traditional | 02/19/2003SE |
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Questions and answers
When was V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control cleared by the FDA?
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (K192931) received a 510(k) decision of Substantially Equivalent on April 19, 2022, 915 days after the submission was received.
What is the product code of K192931?
The FDA product code is GKA – Abnormal Hemoglobin Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7415.