BK251272 · Alba Bioscience Limited United Kingdom · KSS · Nov 14, 2025 · Hematology
Device Facts
Record ID
BK251272
Device Name
Alba Elution Kit
Applicant
Alba Bioscience Limited United Kingdom
Product Code
KSS · Hematology
Decision Date
Nov 14, 2025
Decision
SESE
Regulation
21 CFR 864.9050
Device Class
Class 1
Indications for Use
The Alba Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification. The Alba Elution Kit is an accessory for sample preparation only and does not return diagnostic results for an analyte. Intended for professional use within a blood donor or clinical laboratory environment to perform acid elution of antibodies relating to transfusion in the general population. Single use. For prescription use only.
Device Story
Alba Elution Kit is a sample preparation accessory for blood bank laboratories; used by professionals to dissociate bound antibodies from red blood cells. Kit includes Concentrated Wash Solution, Elution Solution (low pH glycine buffer with indicator), and Buffering Solution (Trizma base). Process: Wash red blood cells to remove unbound antibodies; add Elution Solution to dissociate antibody-antigen complex; add Buffering Solution to restore pH (indicated by blue color change). Output is a neutralized eluate suitable for subsequent serological testing. Facilitates antibody identification; does not provide diagnostic results.
Clinical Evidence
No clinical diagnostic performance data (sensitivity/specificity) presented as the device is a sample preparation accessory. Performance established via comparative bench study against predicate Immucor ELU II Elution Kit. Studies included sample stability (post-bleed and post-elution), anticoagulant compatibility (EDTA vs CPDA), and reproducibility/repeatability testing. Results demonstrated equivalent performance to the predicate.
Technological Characteristics
Kit components: Concentrated Wash Solution (glycine, bovine serum albumin, 0.85% sodium azide), Elution Solution (low pH glycine buffer with pH indicator), and Buffering Solution (Trizma base, bovine serum albumin, <0.1% sodium azide). Supplied in Nalgene bottles and glass vials. Principle: Acid-mediated dissociation of antibody-antigen complexes followed by pH neutralization. Manual procedure.
Indications for Use
Indicated for professional use in blood donor or clinical laboratory environments to perform acid elution of antibodies from intact red blood cells for transfusion-related testing in the general population.
Regulatory Classification
Identification
Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
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Alba Elution Kit
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## 510(k) Summary
### Date
November 07, 2025
### Submitter
Alba Bioscience Limited
5 James Hamilton Way
Milton Bridge
Penicuik
Midlothian
EH26 0BF
United Kingdom
### Contact
Mick Fenton
(b) (6)
Telephone: (b) (6)
Email: (b) (6) @alivedx.com
### Device Information
| *TRADE Name:* | Alba Elution Kit |
| --- | --- |
| *Common Name:* | Blood bank supplies |
| *Classification Name:* | Supplies, Blood-Bank |
| *Regulation Number:* | 21 CFR 864.9050 |
| *Review Panel:* | Hematology |
| *Product Code:* | KSS |
| *Device Class:* | 1 |
### Legally Marketed Predicate Device
| Predicate # | Predicate Trade Name | Product Code |
| --- | --- | --- |
| BK830014 | Elu-Kit II | KSS |
### Device Description Summary
The Alba Elution Kit consists of three components; a Concentrated Wash Solution, Elution Solution and Buffering Solution intended for the acid elution of bound antibodies from intact red blood cells.
The Concentrated Wash Solution is a glycine buffered solution containing bovine serum albumin and preservative 0.85% sodium Azide. It is diluted 1 in 10 to prepare the Working Wash Solution, which is used to wash the red blood cells to remove unbound antibodies.
The Elution Solution is a low pH glycine buffer containing a pH indicator, used to dissociate the antibody-antigen complex on the red blood cells. The recovered eluate is returned to a suitable pH for serological testing by the addition of the Buffering Solution. This appearance of a blue colour indicates that the eluate has been restored to a suitable pH range for testing.
The Buffering Solution is a solution containing tris hydroxymethyl aminomethane (Trizma base), bovine serum albumin and preservative <0.1% sodium Azide.
---Alba Bioscience Limited | 5JamesHamiltonWay | Penicuik Midlothian UK
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Alba Elution Kit
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Concentrated Wash Solution is supplied in a 30 mL Nalgene bottle, and the Elution Solution and Buffering Solution are both supplied in 10 mL glass vials with a dropper.
The Alba Elution Kit components are packaged in a labelled cardboard carton.
### **Intended Use/ Indications for Use**
The Alba Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification.
The Alba Elution Kit is an accessory for sample preparation only and does not return diagnostic results for an analyte.
Intended for professional use within a blood donor or clinical laboratory environment to perform acid elution of antibodies relating to transfusion in the general population.
Single use.
For prescription use only.
### **Indications for Use Comparison**
The Indications for Use for the Alba Elution Kit are the same as for the marketed Immucor Elu-Kit II device.
### **Technological Comparison**
The classification, intended use, composition, mode of action, and safety and effectiveness of the subject device, Alba Elution Kit, and the US legally marketed predicate Elu Kit -II (BK830014, are substantially equivalent.
### **Non-Clinical and/or Clinical Tests**
As the Alba Elution Kit is an accessory for sample preparation only and does not return diagnostic results, clinical performance evaluation data cannot be presented as diagnostic performance characteristics such as sensitivity and specificity. As such, clinical performance is defined as the agreement of results between the Alba Elution Kit and the currently marketed Immucor ELU II Elution Kit.
A study was performed at one internal site in Alba Biosciences Ltd., Edinburgh, United Kingdom with testing conducted from 03 Jul 2023 to 03 Aug 2023.
Sample Stability and Anticoagulant Studies demonstrate the length of time post bleed samples can be used in the elution procedure and the length of time eluates can be tested post elution when stored at 2 to 8 °C. In addition, results demonstrate equivalent results are returned between EDTA and CPDA anticoagulants.
Reproducibility and Interoperability studies demonstrate the performance of the Alba Elution Kit is repeatable and reproducible.
The comparator study demonstrated equivalent performance of the Alba Elution Kit to that of the predicate Immucor ELU II Elution Kit.
### **Summary & Conclusions**
The non-clinical testing and comparison to the predicate device show the subject Alba Elution Kit to be substantially equivalent to the predicate device.
In conclusion, the Alba Elution Kit is substantially equivalent to the predicate device in terms of functionality, performance, technological characteristics, and Indications for Use, including for safety and effectiveness.
---Alba Bioscience Limited | 5JamesHamiltonWay | Penicuik Midlothian UK
