BK251265 · Alba Bioscience Limited United Kingdom · KSS · Nov 12, 2025 · Hematology
Device Facts
Record ID
BK251265
Device Name
ORTHO® Elution Kit
Applicant
Alba Bioscience Limited United Kingdom
Product Code
KSS · Hematology
Decision Date
Nov 12, 2025
Decision
SESE
Regulation
21 CFR 864.9050
Device Class
Class 1
Indications for Use
The Ortho® 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 Ortho 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
Ortho® Elution Kit is a blood bank accessory for acid elution of bound antibodies from red blood cells. Components include Concentrated Wash Solution (glycine buffer, bovine serum albumin, sodium azide), Elution Solution (low pH glycine buffer with pH indicator), and Buffering Solution (Trizma base, bovine serum albumin, sodium azide). Procedure involves washing red blood cells to remove unbound antibodies, dissociating antibody-antigen complexes using low pH Elution Solution, and restoring pH using Buffering Solution; blue color indicator confirms appropriate pH for subsequent serological testing. Used in clinical or blood donor laboratories by trained professionals. Output is a prepared eluate sample for further antibody detection/identification. Device does not provide diagnostic results; serves as sample preparation tool.
Clinical Evidence
No clinical diagnostic performance data (sensitivity/specificity) presented as the device is a sample preparation accessory. Performance established via bench-top comparator study against predicate Immucor ELU II Elution Kit. Studies included sample stability, anticoagulant compatibility (EDTA vs CPDA), reproducibility, and interoperability. Results demonstrated equivalent performance between subject and predicate devices.
Technological Characteristics
Kit consists of three liquid reagents: Concentrated Wash Solution (glycine buffer, 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 bottle and glass vials. Principle of operation is chemical acid elution. No electronic, software, or energy-based components.
Indications for Use
Indicated for professional use in blood donor or clinical laboratory settings 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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Ortho® 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
Regulatory Affairs Contractor
Telephone: **(b) (6)**
Email: mick.fenton@alivedx.com
### Device Information
| *TRADE Name:* | Ortho® 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 Ortho® 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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Ortho® 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 Ortho® Elution Kit components are packaged in a labelled cardboard carton.
### **Intended Use/ Indications for Use**
The Ortho® 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 Ortho 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 Ortho® 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, Ortho® Elution Kit, and the US legally marketed predicate Elu Kit -II (BK830014, are substantially equivalent.
### **Non-Clinical and/or Clinical Tests**
As the ORTHO 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 Ortho® 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 Ortho® Elution Kit is repeatable and reproducible.
The comparator study demonstrated equivalent performance of the Ortho® 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 Ortho® Elution Kit to be substantially equivalent to the predicate device.
In conclusion, the Ortho® 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
