← Product Code [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX) · K032936

# DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR (K032936)

_Stanbio Laboratory · JIX · Mar 12, 2004 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K032936

## Device Facts

- **Applicant:** Stanbio Laboratory
- **Product Code:** [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX.md)
- **Decision Date:** Mar 12, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1150
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

Direct LDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma. LDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders. For In Vitro Diagnostic use only. Prescription use

## Device Story

System uses two-reagent homogenous method to measure serum/plasma LDL-Cholesterol directly without pretreatment or centrifugation. Reagent 1 (detergent, phosphoric acid compounds) binds HDL, VLDL, and chylomicrons, isolating LDL particles. Reagent 2 (enzymes) reacts with isolated LDL-cholesterol to produce measurable color change. Used in clinical laboratory settings by trained personnel. Output is quantitative LDL-C concentration. Results assist clinicians in diagnosing and managing lipid metabolism disorders, enabling targeted patient treatment.

## Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A (within-day CV 0.44-0.56%; day-to-day CV 1.33-1.43%). Linearity confirmed to 520 mg/dL per EP6-P. Method comparison against predicate (N=62) yielded Y=1.025X-4.0289, r=0.9969. Analytical specificity demonstrated against hemoglobin, bilirubin, ascorbic acid, and chylomicrons. No clinical studies performed.

## Technological Characteristics

Homogenous enzymatic colorimetric assay. Two-reagent system: R1 contains detergent and phosphoric acid compounds; R2 contains enzymes. Measures absorbance change. Linear range up to 700 mg/dL. In vitro diagnostic use.

## Regulatory Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Predicate Devices

- LDL Cholesterol Plus (k012287)

## Submission Summary (Full Text)

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

A. 510(k) Number:
k032936

B. Analyte:
Low Density Lipoprotein (LDL) Cholesterol

C. Type of Test:
Quantitative

D. Applicant:
Stanbio Laboratory

E. Proprietary and Established Names:
Stanbio Laboratory Direct LDL Cholesterol LiquiColor®
Stanbio Direct HDL/LDL Cholesterol Calibrator

F. Regulatory Information:
1. Regulation section:
21 CFR § 862.1475, Lipoprotein Test System
862.1150, Calibrator
2. Classification:
Class I, Class II
3. Product Code:
MRR,
JIX
4. Panel:
Clinical Chemistry (75)

G. Intended Use:
1. Indication(s) for use:
Direct LDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma. LDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

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2. Special condition for use statement(s):
For In Vitro Diagnostic use only.
Prescription use

3. Special instrument Requirements:
Hitachi® 917 analyzer

## H. Device Description:

The device is a system using the reagent and calibrator in combination to directly measure the LDL-Cholesterol. This is achieved by a homogenous method that directly measures serum LDL-Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically bind HDL, VLDL and chylomicrons leaving the LDL particles exposed. The second reagent (R2) contains enzymes, which then reacts with LDL cholesterol present in the sample. Consequently, only the LDL cholesterol is subject to cholesterol measurement.

## I. Substantial Equivalence Information:

1. Predicate device name(s):
LDL Cholesterol Plus

2. Predicate K number(s):
k012287

3. Comparison with predicate:
Both devices are for the quantitative determination of the same analyte in the same matrixes. Both devices employ enzymatic colorimetric reaction.

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

National Cholesterol Education Program (NCEP) guidelines “Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication No. 01-3670: May 2001
NCCLS EP5-A - Evaluation of Precision Performance of Clinical Chemistry Devices
NCCLS EP6-P - Evaluation of the Linearity of Quantitative Analytical Methods
NCCLS EP9-A - Method Comparison and Bias Estimation Using Patient Samples

## K. Test Principle:

The tests employ enzymatic colorimetric reaction. The increase in absorbance due to color intensity generated during the reaction is measured photometrically, and is proportional to the LDL-Cholesterol concentration.

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

## 1. Analytical performance:

### a. Precision/Reproducibility:

Within-Day and Day-to-Day precision for the Direct HDL Cholesterol LiquiColor method was determined following a modification of NCCLS EP5-A. Results are summarized below.

Within – Day; N=10

|   | Sample 1 | Sample 2  |
| --- | --- | --- |
|  Mean(mg/dL) | 50 | 99  |
|  SD | 0.28 | 0.49  |
|  % CV | 0.56 | 0.44  |

Day –to –Day (24 days; N=17)

|   | Sample 1 | Sample 2 | Sample 3  |
| --- | --- | --- | --- |
|  Mean(mg/dL) | 97 | 138 | 204  |
|  SD | 1.29 | 1.92 | 2.90  |
|  % CV | 1.33 | 1.40 | 1.43  |

### b. Linearity/assay reportable range:

Performed according to NCCLS Guideline EP6-P, the results show this method is linear to 520 mg/dL.

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

The value of this calibrator was assigned by procedures traceable to the National Reference System for Cholesterol (NRS/CHOL). This reagent system was not tested or certified by the CRMLN (Cholesterol Reference Method Laboratory Network).

### d. Sensitivity:

Based on an instrument resolution of A=0.001 absorbance units, this reagent has a sensitivity of 0.4 mg/dL of LDL cholesterol. This was demonstrated in a study assaying a sample of known concentration in 20 replicates.

### e. Analytical specificity:

The test is not influenced by hemoglobin values up to 500 mg/dL, bilirubin levels up to 40 mg/dL, ascorbic acid up to 50 mg/dL, and chylomicrons up to 3000 mg/dL. This was demonstrated in a study using two samples spiked with interferant.

### f. Assay cut-off:

NA

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2. Comparison studies:

a. Method comparison with predicate device:

Linear regression analysis of 62 serum samples with LDL cholesterol levels ranges from 22 to 178 mg/dL was performed, comparing the subject product (Y) to the predicate (X) with the following results:

$$
\mathrm {Y} = 1. 0 2 5 \mathrm {X} - 4. 0 2 8 9 \quad \mathrm {r} = 0. 9 9 6 9
$$

b. Matrix comparison study in which one sample was split as follows:

|  Samples | Type of blood tube | Assay  |
| --- | --- | --- |
|  Serum | Reference (drawn by syringe) | 110.7  |
|  Serum | Plain Blood Tube | 111.1  |
|  Serum | With additive for isolation | 109.7  |
|  Serum | Thrombin Blood Tube | 110.5  |
|  Plasma | Heparin Lithium + polyester Gel Blood tube | 108.0  |
|  Plasma | Heparin Lithium + Acetic Iodide Lithium Blood Tube | 105.6  |
|  Plasma | Heparin Sodium + Na F Blood Tube | 98.0  |

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: NA

5. Expected values/Reference range:

According to NCEP recommendations for patients classifications are suggested for the prevention and management of coronary heart disease, Optimal: <100 mg/dL (2.58 mmol/L)

Near Optimal: 100-129 mg/dL (2.59-3.34 mmol/L)

Borderline High: 130-159 mg/dL (3.36-4.11 mmol/L)

High: 160-189mg/dL (4.14-4.88 mmol/L)

Very High: ≥190 mg/dL (≥4.90 mmol/L)

It is recommended that each laboratory establish its own range of expected values, since differences exist between instruments, laboratories, and local populations.

M. Conclusion:

I recommend that the Stanbio Laboratory Direct LDL Cholesterol LiquiColor® and Stanbio Direct HDL/LDL Cholesterol Calibrator are substantially equivalent to the legally marketed predicate device.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K032936](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K032936)

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