← Product Code [JPK](/submissions/HE/subpart-i%E2%80%94hematology-reagents/JPK) · K081641

# COULTER LIN-X LINEARITY CONTROL (K081641)

_Beckman Coulter, Inc. · JPK · Jan 16, 2009 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JPK/K081641

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [JPK](/submissions/HE/subpart-i%E2%80%94hematology-reagents/JPK.md)
- **Decision Date:** Jan 16, 2009
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8625
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

COULTER LIN-X linearity controls are intended to assess calibration and verify the reportable range of COULTER cellular analysis systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents.

## Device Story

COULTER LIN-X linearity controls consist of stabilized human blood components; concentrations of WBC, RBC, HGB, and PLT span the reportable range of specific COULTER cellular analysis systems. Used in clinical laboratory settings to assess instrument calibration and verify reportable ranges. Healthcare providers compare repeated measurement results against established expected ranges provided in product manuals or online help systems. This verification process ensures the accuracy and reliability of the hematology analyzer's performance, supporting clinical decision-making by confirming the validity of patient sample analysis.

## Clinical Evidence

Bench testing only. Studies conducted on stability, calibration assessment, value assignment, and range determination demonstrated acceptable performance per manufacturing specifications.

## Technological Characteristics

Stabilized human blood components. Designed for use with COULTER cellular analysis systems. Provides multiple concentration levels to span reportable ranges for WBC, RBC, HGB, and PLT.

## Regulatory Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

## Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Predicate Devices

- COULTER® LIN-C® Linearity Control ([K955334](/device/K955334.md), [K061064](/device/K061064.md))
- CBC-Line Hematology Linearity Kit ([K942822](/device/K942822.md))

## Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K081641

B. Purpose for Submission:
New Device

C. Measurand:
White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB), Platelets (PLT)

D. Type of Test:
Quantitative

E. Applicant:
Beckman Coulter, Inc.

F. Proprietary and Established Names:
COULTER® LIN-X Linearity Control

G. Regulatory Information:
1. Regulation section:
21 CFR 864.8625
2. Classification:
Class II
3. Product code:
JPK

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4. Panel:
81 (Hematology)

H. Intended Use:

1. Intended use(s):
COULTER LIN-X linearity controls are intended to assess calibration and verify the reportable range of COULTER cellular analysis systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents.

2. Indication(s) for use:
COULTER LIN-X linearity controls are intended to assess calibration and verify the reportable range of COULTER cellular analysis systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents.

3. Special conditions for use statement(s):
Not applicable.

4. Special instrument requirements:
For use on the COULTER LH750 and COULTER LH780 Hematology Analyzer, and the UniCel DxH 800 Cellular Analysis System.

I. Device Description:
COULTER LIN-X Linearity Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic medium. LIN-X Linearity Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. The WBC, RBC, HGB and PLT concentrations span the instrument's reportable range. Results from repeated measurements for each concentration are compared to the established expected range to assess the instrument's calibration and verify the reportable range.

COULTER LIN-X Linearity Control is a multi-level control product manufactured in vial (3.3ml) configurations (levels 0-11).

J. Substantial Equivalence Information:

1. Predicate device name(s):
COULTER® LIN-C® Linearity Control (Cleared as COULTER® Linearity Controls)

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CBC-Line Hematology Linearity Kit, R&D Systems, Inc.

# 2. Predicate K number(s):

K955334, K061064

K942822

# 3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|   | COULTER® LIN-X Linearity Control | COULTER® LIN-C® Linearity Control  |
|  Intended use | Same except calibration assessment added. | COULTER LIN-C linearity controls are intended to verify the reportable range of COULTER hematology analyzers  |
|  Final Product Form | Same except twelve levels (Levels 0-11) | Eleven levels (Levels 0-10), liquid, ready to use reagent  |
|  Cellular Parameters | Same | Erythrocytes, Platelets, Monocytes  |
|  Range Covered | Same for WBC, RBC, and HGB PLT: 0 - 5000 x 103 | WBC: 0 - 400 x 103RBC: 0 - 8.0 x 106HGB: 0 - 25PLT: 0 - 3000 x 103  |
|  Expected Values Provided | ·Assay values and expected ranges provided for each assayed parameter per level which result in a narrower acceptable recovery range relative to LIN-C controls for most parameter levels. ·Acceptable maximum value recovery provided for Level 0. | Acceptable ranges (low and high values) provided for each assayed parameter per level.  |
|  Open vial stability | 7 days when stored at 2 - 8°C | Same  |
|  Closed Vial Stability | 120 Days when stored at 2 8°C | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | COULTER® LIN-X Linearity Control | COULTER® LIN-C® Linearity Control  |
|  Analyzers | COULTER® LH 750, COULTER® LH 780, COULTER® UniCel® DxH 800 Cellular Analysis System | COULTER® LH 780, LH 750, LH 500, GenS, HmX, MaxM, MaxM A/L, Onyx, AcT Series, AcT Diff, AcT Diff 2, MD, MD II, T Series, JT, JT2/3, STKS  |

# K. Standard/Guidance Document Referenced (if applicable):

Not applicable.

# L. Test Principle:

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CLIA requires that laboratories establish and verify the performance specification, accuracy, precision and reportable range, of new instrumentation upon installation, following significant preventive maintenance, unusual trends / shifts in control recovery or when recommended by the instrument manufacturer. COULTER LIN-X Linearity controls can be used on calibrated instruments to comply with these guidelines. The product's WBC, RBC, HGB and PLT concentrations span the instrument's reportable range. Results from repeated measurements for each concentration are compared to the established expected range, to assess the instrument's calibration and to verify the reportable range.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

**a. Precision/Reproducibility:**

Reproducibility and precision is captured within the range determination study with data generated from two studies: 1) closed vial stability and 2) open vial stability.

**b. Linearity/assay reportable range:**

Not applicable.

**c. Traceability, Stability, Expected values (controls, calibrators, or methods):**

**Value assignment:** Value assignments for each lot are determined on validated systems using Beckman Coulter reagents on appropriate instruments. One hundred ten (110) vials from each lot are taken randomly throughout the production run. For each value assignment process, two assay runs are required on the appropriate instrument on separate days. Four to six sample tubes are analyzed for each assay run. An assay computer system is used to determine the number of replicates required for each assay run and analyze the data in real time. Zero biased, equilibration adjusted data and the raw instrument assay run data is used to determine the final value assignment. The value assignments are confirmed by analyzing one to two tubes for a total of 10 aspirations on the appropriate instrument.

**Open vial stability:** Open vial testing consists of six aspirations from two vials per level repeated once a month. Multiple lots of the new level of LIN-X Linearity Control (Level 10) were tested monthly. Two vials were evaluated at each time point. For samples analyzed on the LH 750, 1:1 dilutions were prepared at each time point since the Platelet count exceeded the linear range of the instrument. On the LH 750 Hematology Analyzer, a single run was performed on Day 1 to initiate the open vial condition followed by six runs on

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Day 7 to validate the open vial claim of seven days. On the DxH 800 Cellular Analysis System, six runs were performed on both Day 1 and Day 7. The mean recovered values were compared to the assay values and expected ranges for the additional level.

Closed vial stability: Closed vial testing consisted of six aspirations taken from one vial per level approximately 3 times per month. Multiple lots of the new level of LIN-X Linearity Control (Level 10) were tested 3 times per month. For samples analyzed on the LH 750, 1:1 dilutions were prepared at each time point since the Platelet count exceeded the linear range of the test instrument. The mean recovered values were compared to the assay values and expected ranges for the additional level.

Calibration Assessment Study: LIN-X linearity controls and CBC-Line linearity controls (predicate) were tested on four instruments to demonstrate that they yield equivalent results for calibration assessment / verification. LIN-X linearity control results were assess against the assay values and expected ranges.

Table 1: Summary Statistics for Level 10 Platelet on LH 750 with LH Series Reagents

|   | Set 2 | Set 3 | Set 4 | Set 5  |
| --- | --- | --- | --- | --- |
|  Mean | 4949 | 4741 | 4741 | 4504  |
|  SD | 228.3 | 355.5 | 355.5 | 158.4  |
|  %CV | 4.6 | 7.5 | 7.5 | 3.5  |

Table 2: Summary Statistics for Level 10 Platelet on LH 750 with System V Reagents

|   | Set 2 | Set 3 | Set 4 | Set 5  |
| --- | --- | --- | --- | --- |
|  Mean | 4831 | 4704 | 5170 | 4645  |
|  SD | 244.5 | 330.0 | 174.5 | 148.3  |
|  %CV | 5.1 | 7.0 | 3.4 | 3.2  |

Table 3: Summary Statistics for Level 10 Platelet on DxH 800 Cellular Analysis System

|   | 9021BC-853  |
| --- | --- |
|  Mean | 5072  |
|  SD | 112.7  |
|  %CV | 2.2  |

d. Detection limit:

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Not applicable.

e. Analytical specificity:
Not applicable.

f. Assay cut-off:
Not applicable.

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable.
b. Matrix comparison:
Not applicable.

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
The expected ranges were established for each level statistically, based on data collected on multiple instruments and lots controls using specific Beckman Coulter reagents. Total variability is calculated for each parameter. The expected ranges are based on system performance and provided in the Table of Expected Results.

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N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JPK/K081641](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JPK/K081641)

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