Adaptive Nomogram Bottle

BK251160 · Fresenius Kabi AG Lake Zurich, IL · KSR · Feb 21, 2025 · Hematology

Device Facts

• Record ID: BK251160
• Device Name: Adaptive Nomogram Bottle
• Applicant: Fresenius Kabi AG Lake Zurich, IL
• Product Code: KSR · Hematology
• Decision Date: Feb 21, 2025
• Decision: SESE
• Regulation: 21 CFR 864.9100
• Device Class: Class 2

Indications for Use

For the collection, storage, and shipment of plasma prior to fractionation.

Device Story

Adaptive Nomogram Bottle; empty, semi-rigid, single-use, sterile fluid path collection bottle. Used for collection, storage, and shipment of source plasma prior to fractionation. Utilized with disposable sets and plasmapheresis systems. Operates as passive container; no active processing or electronic components. Used in clinical/collection center settings by trained personnel. Facilitates plasma handling for fractionation; ensures sterile containment.

Clinical Evidence

Bench testing only. Performance verified using same methods as previously cleared predicate; passed all acceptance criteria.

Technological Characteristics

Semi-rigid, single-use, non-pyrogenic, sterile fluid path collection bottle. Materials and components identical to predicate. No electronic or software components.

Indications for Use

Indicated for the collection, storage, and shipment of source plasma prior to fractionation in patients undergoing plasmapheresis.

Regulatory Classification

Identification

An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.

Predicate Devices

• Plasmalink Bottle with Locking Luer Adapter (BK190362)

Submission Summary (Full Text)

{0}


**Fresenius Kabi**
Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 888-391-6300
www.fresenius-kabi.us

February 19, 2025

## 510(K) SUMMARY

| Contact Details | |
| --- | --- |
| Applicant Name | Fresenius Kabi AG |
| Applicant Address | Else-Kröner-Str. 1 Bad Homburg 61352 Germany |
| Correspondent Name | Fresenius Kabi |
| Correspondent Address | Three Corporate Drive Lake Zurich IL 60047 United States |
| Correspondent Contact Telephone | 847-550-2696 |
| Correspondent Contact | Kaluki Munyao |
| Correspondent Contact Email | [e-mail] |

| Device Name | |
| --- | --- |
| Device Trade Name | Adaptive Nomogram Bottle |
| Common Name | Plasma Pooling Bottle, Plasma Bottle, Pooling Bottle |
| Classification Name | Container, Empty, For Collection & Processing of Blood & Blood Components |
| Regulation Number | 864.9100 |
| Product Code | KSR |

| Legally Marketed Predicate Devices | |
| --- | --- |
| Predicate 510(k) Number | BK190362 |
| Predicate Trade Name | Plasmalink Bottle with Locking Luer Adapter |
| Product Code | KSR |

| Device Description Summary | |
| --- | --- |
| Plasma bottles are empty, semi rigid, single use, non-pyrogenic and sterile fluid path collection bottles intended for the collection, storage and shipment of source plasma prior to fractionation. Plasma bottles are utilized in conjunction with applicable disposable sets and applicable plasmapheresis systems. | |

| Intended Use/Indications for Use | |
| --- | --- |
| For the collection, storage, and shipment of plasma prior to fractionation. | |

---Page 1 of 2

{1}

### **Indications for Use Comparison**

The intended use/indications for use of the Adaptive Nomogram Bottle is the same as the predicate device.

### **Technological Comparison**

The Adaptive Nomogram Bottle has the same performance characteristics, the same components, and the same materials as the predicate devices. The changes described in this application did not affect the fundamental scientific technology or principle of operation of the device.

### **Non-Clinical and/or Clinical Tests Summary & Conclusions**

The performance of the Adaptive Nomogram Bottle was verified by the same methods used in the previously cleared submission and passed the acceptance criteria. The intended use, fundamental scientific technology, safety and effectiveness of the proposed device remain unchanged from the predicate device. Based on the verification activities performed, the Adaptive Nomogram Bottle is substantially equivalent to the predicate device.

---Page 2 of 2