AKERS LABORATORIES INC. BLOOD CELL SEPARATOR

K030815 · Akers Laboratories, Inc. · JKA · Sep 17, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030815
• Device Name: AKERS LABORATORIES INC. BLOOD CELL SEPARATOR
• Applicant: Akers Laboratories, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The Blood Cell Separator is intended for use as a sample preparation aid to in vitro lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen. The liquid produced by device is dependent upon the sample collected; whole blood collected with an anti-coagulant will produce plasma, and whole blood collected without an anti-coagulant will produce serum.

Device Story

The Blood Cell Separator is a manual sample preparation device used to collect and separate serum or plasma from whole blood specimens for lithium colorimetric diagnostic testing. The device consists of a multi-layer membrane system and a capillary tube. Whole blood is applied to the membrane surface; the membrane captures blood cells while the residual liquid flows laterally to the tip of the membrane. The capillary tube then fills via capillary action to a fixed, controlled volume. The device eliminates the need for centrifugation and manual intervention during the separation process. It is intended for use in clinical settings where precise micro-volume samples are required. The resulting serum or plasma is then used by healthcare providers for diagnostic analysis, facilitating patient lithium level monitoring.

Clinical Evidence

Bench testing only. Precision study (n=200) compared lithium measurement results between the subject device and BD Vacutainer system; composite %CV was 8.4% (low) and 5.7% (high) for the subject device versus 9.5% and 6.1% for the predicate. Method comparison study (n=25) using spiked whole blood samples (0.1–2.5 mEq/L) yielded R=0.993 and R²=0.9866 compared to centrifugation. Analytical sensitivity was 0.03 mEq/L for both methods.

Technological Characteristics

Consists of a lectin-coated multi-layer membrane system and a capillary tube. Separation principle: filtration via lectin-coated membrane. Energy source: none (passive wicking). Form factor: membrane system and capillary tube assembly. No software or electronic components.

Indications for Use

Indicated for use as a sample preparation aid for in vitro lithium colorimetric diagnostic testing. Collects precise micro-volumes of serum or plasma from whole blood specimens for patients requiring lithium level monitoring.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• Vacutainer® Brand Tube for the Determinations Requiring Serum (Pre-amendment)
• Vacutainer® Brand Tube for Hematology and Selective Chemistry Determination (Pre-amendment)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE

A. 510(k) Number:
K030815

B. Analyte:
Blood separation

C. Type of Test:
Sample preparation for lithium testing

D. Applicant:
Akers Laboratories, Inc.

E. Proprietary and Established Names:
Blood Cell Separator

F. Regulatory Information:
1. Regulation section:
862.1675; Tubes, vials, systems, serum separators, blood collection
2. Classification:
Class II
3. Product Code:
JKA
4. Panel:
75

G. Intended Use:
1. Indication(s) for use:
The Blood Cell Separator is intended for use as a sample preparation aid to *in vitro* lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen. The liquid produced by device is dependent upon the sample collected; whole blood collected with an anti-coagulant will produce plasma, and whole blood collected without an anti-coagulant will produce serum.
2. Special condition for use statement(s):
NA
3. Special instrument Requirements:
NA

H. Device Description:
The Blood Cell Separator consists of two components packaged in a single separator device: the membrane system and a capillary tube. Twenty five of each are packaged in the carton.

I. Substantial Equivalence Information:
1. Predicate device name(s):
BD Vacutainer™ glass serum tube, no additive; BD Vacutainer™ EDTA tube
2. Predicate K number(s):
Both BD tubes are pre-amendment
3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | Blood Cell Separator | BD Vacutainers |
| Intended use | Used to collect and separate blood specimen | Used to collect and separate blood specimens |
| Principle | Separates cells directly; produces a liquid fraction | Separates cells directly; produces a liquid fraction |
| Differences | | |
| Item | Blood Cell Separator | BD Vacutainers |
| Separation method | Filtration using lectin coated membrane system | Centrifugation |

J. Standard/Guidance Document Referenced (if applicable):
CDRH Guidance: Medical Device Labeling - Suggested Format and Content; Draft Document Issued on April 25, 1997

K. Test Principle:
The Blood Cell Separator is based upon a multiple layer membrane system coated with lectin designed to separate blood cells and serum/plasma. Whole blood applied to the surface of the membrane system results in serum/plasma which wicks laterally through the device. The residual liquid will then migrate laterally and flow into the capillary tube.

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Two levels of lithium samples, "Low" and "High" containing 0.5 and 1.2 mEq/L Lithium respectively were each assayed in 10 separation runs per day for 5 days (200 tests). Lithium was measured on the Genysys 5 Spectrophotometer using Trace Lithium Reagent and Standard (K003583). The daily standard deviation obtained during the five (5) day precision study for the Blood Cell Separator ranged from 0.01 mEq/L to 0.04 mEq/L for the low value sample and 0.03 mEq/L to 0.07 mEq/L for the high value sample compared to daily standard deviations for the BD Vacutainer™ system of 0.03 mEq/L to 0.08 mEq/L and 0.03 mEq/L to 0.08 mEq/L respectively for the low and high value samples. The composite percent coefficient of variation (%CV) for the Blood Cell Separator system based on 50 samples over 5 days was 8.4% for the low value sample and 5.7% for the high value sample compared to 9.5% and 6.1%, respectively for the BD Vacutainer™ system. These results illustrated equivalent precision performance of the blood cell separator system when compared to the BD Vacutainer™ system.
b. Linearity/assay reportable range:
NA

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c. Traceability (controls, calibrators, or method): NA

d. Detection limit:
The assay sensitivity was 0.03 mEq/L with BD Vacutainer™ Tube EDTA plasma separation and 0.03 mEq/L using the Akers Blood Cell Separator separation method illustrating equivalent performance. The data showed that the plasma produced by the Blood Cell Separator did not significantly alter values produced by these samples. Lithium was measured on the Genysys 5 Spectrophotometer using Trace Lithium Reagent and Standard (K003583).

e. Analytical specificity: NA

f. Assay cut-off: NA

2. Comparison studies:

a. Method comparison with predicate device:
Studies were performed comparing samples separated with the Blood Cell Separator and EDTA whole blood collected in BD Vacutainer™ tubes. Twenty five spiked whole blood samples, ranging from 0.1 to 2.5 mEq/L at 0.1 mEq/L intervals were separated using the Blood Cell Separator and compared to whole blood collected in BD Vacutainer™ tubes with the plasma separated by centrifugation. Lithium was measured on the Genysys 5 Spectrophotometer using Trace Lithium Reagent and Standard (K003583). The comparison yielded an R value of 0.993 and an R² value of 0.9866.

b. Matrix comparison: NA

3. Clinical studies:

a. Clinical sensitivity: NA

b. Clinical specificity: NA

c. Other clinical supportive data (when a and b are not applicable): NA

4. Clinical cut-off: NA

5. Expected values/Reference range: NA

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M. Conclusion:

Based upon a Third Party Review of the information provided in this 510(k), this device is substantially equivalent to devices regulated by 21 CFR 862.1675, tubes, vials, systems, serum separators, blood collection; 75 JKA; Class II.

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