NOD CHEMISTRY CONTROL

K060850 · Bioresource Technology, Inc. · JJY · May 30, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060850
• Device Name: NOD CHEMISTRY CONTROL
• Applicant: Bioresource Technology, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The NOD™ Chemistry Control is a two-level control set that is intended for in-vitro diagnostic use to monitor the precision of laboratory testing procedures for the analytes listed in the package insert (routine chemistries).

Device Story

NOD™ Chemistry Control is a two-level control set used in clinical laboratories to monitor the precision of routine chemistry testing procedures. It serves as a quality control material to ensure the accuracy and reliability of diagnostic assays. The device is intended for professional use by laboratory personnel. By providing known values for specific analytes, it allows clinicians to verify that testing equipment and reagents are performing within established parameters, thereby supporting consistent clinical decision-making and patient diagnostic accuracy.

Clinical Evidence

No clinical data. Bench testing only. Stability validated via real-time aging studies at 4°C, measuring concentration changes over 35 days (unopened) and 14 days (opened) for 28 analytes, confirming performance within company-accepted ranges.

Technological Characteristics

Two-level control set for in-vitro diagnostic use. Classified as Class I quality control material under 21 CFR 862.1660. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for in-vitro diagnostic use to monitor the precision of laboratory testing procedures for routine chemistry analytes.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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

A. 510(k) Number:
k060850

B. Purpose for Submission:
Clearance to market quality control material.

C. Measurand:
Control material for ALT, albumin, ALP, amylase, AST, bilirubin- total and direct, BUN, calcium, $\mathrm{CO}_{2}$, chloride, cholesterol (total, HDL, and LDL), CK, CK-MB, creatinine, CRP, fructosamine, GGT, glucose, iron, lactate, LDH, lipase, lithium, magnesium, phosphorus, potassium, sodium, total protein, triglycerides, and uric acid.

D. Type of Test:
Quality control material

E. Applicant:
Bioresource Technology, Inc.

F. Proprietary and Established Names:
NOD Chemistry Control

G. Regulatory Information:
1. Regulation section:
21CFR 862.1660, Quality control material (assayed and unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJY, multi-analyte controls, all kinds (assayed and unassayed)

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4. Panel:
(75) Chemistry

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
The NOD™ Chemistry Control is a two-level control set that is intended for in-vitro diagnostic use to monitor the precision of laboratory testing procedures for the analytes listed in the package insert (routine chemistries).

3. Special conditions for use statement(s):
For Prescription Use Only

4. Special instrument requirements:
Not applicable

I. Device Description:

The NOD™ Chemistry Control is a two-level control set that is prepared from purified human serum to which biochemical material (human and animal derived), drugs, chemicals, stabilizers, and preservatives have been added. Individual donor units used in the preparation of the controls were tested using FDA-cleared methods for anti-HIV-1 and 2, HBsAG, anti-HCV, HIV-1 antigens, and syphilis, and found to be non-reactive.

The controls are supplied in a pre-packaged liquid form to avoid potential error or contamination that could be introduced during reconstitution. The controls are tested in the same manner as clinical specimens, and therefore should be assayed according to the instructions accompanying the laboratory instrument, kit, or reagent system being used.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Bio-Rad Multiqual® 1, 2, 3

2. Predicate 510(k) number(s):

2

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k043208

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The NOD™ Chemistry Control is a two-level control set that is intended for in-vitro diagnostic use to monitor the precision of laboratory testing procedures for the analytes listed in the package insert | Same |
| Matrix | Prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added. | Same |
| Form | Liquid, ready-to-use | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | ALT, albumin, ALP, amylase, AST, bilirubin-total and direct, BUN, calcium, C02, chloride, cholesterol- total, HDL, and LDL, CK, CK-MB, creatinine, CRP, fructosamine, GGT, glucose, iron, lactate, LDH, lipase, lithium, magnesium, phosphorus, potassium, sodium, total protein, triglycerides, and uric acid | Additional analytes |
| Stability(unopened storage claim) | 30 days when stored tightly capped at 2-8°C | Not all analytes are stable for 30 days |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Stability(opened vial claim) | 14 days when stored tightly capped at 2-8°C | Not all analytes are stable for 14 days |

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

None referenced.

# L. Test Principle:

Not applicable.

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

# 1. Analytical performance:

a. Precision/Reproducibility:

Not Applicable for a submission of this type.

b. Linearity/assay reportable range:

Not Applicable for a submission of this type.

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

The company assigns values to their controls by assaying 6 randomly selected vials from each manufacturing lot. Vials are measured in triplicate and measured across 3 instruments.

The company assessed the stability of their product through real-time aging studies. Vials were randomly selected from a manufacturing lot and stored at the designated aging temperature. Samples were periodically withdrawn for concentration measurements.

As an example, for sealed samples stored at $4^{\circ}\mathrm{C}$ , the company demonstrated:

| Analyte | Initial Concentration | Concentration at 35 days | Percent Change | Concentration Range Accepted by Company |
| --- | --- | --- | --- | --- |
| Albumin | 5.5 g/dl | 5.4 g/dl | 1.82% | 4.5 - 6.7 |
| Alkaline Phosphatase | 430 U/L | 446 U/L | -3.72% | 345 - 517 |
| ALT | 217 U/L | 211 U/L | 2.76% | 184 - 275 |
| Amylase | 390 U/L | 393 U/L | -0.77% | 312 - 468 |
| AST | 134 U/L | 127 U/L | 5.22% | 98 - 146 |

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| Analyte | Initial Concentration | Concentration at 35 days | Percent Change | Concentration Range Accepted by Company |
| --- | --- | --- | --- | --- |
| Bilirubin-total | 3.3 mg/dl | 3 mg/dl | 9.09% | 2.4 - 3.6 |
| Calcium-total | 11.5 mg/dl | 11.2 mg/dl | 2.61% | 10.0 - 15.0 |
| Chloride | 121 mEq/L | 121 mEq/L | 0.00% | 96 – 144 |
| LD | 187 U/L | 191 U/L | -2.14% | 149 – 225 |
| CK | 771 U/L | 788 U/L | -2.20% | 616 – 926 |
| Creatinine | 1.5 mg/dl | 1.5 mg/dl | 0.00% | 1.3 - 1.9 |
| GGT | 79 U/L | 75 U/L | 5.06% | 63 – 95 |
| Glucose | 177 mg/dl | 181 mg/dl | -2.26% | 138 – 206 |
| Magnesium | 3 mg/dl | 2.9 mg/dl | 3.33% | 2.5 - 3.7 |
| Phosphorus | 5.7 mg/dl | 5.9 mg/dl | -3.51% | 5.0 - 7.4 |
| Potassium | 4.9 mEq/L | 4.9 mEq/L | 0.00% | 4.5 - 6.7 |
| Protein-total | 8.9 g/dl | 8.8 g/dl | 1.12% | 7.0 - 10.6 |
| Sodium | 166 mEq/L | 168 mEq/L | -1.20% | 136 – 204 |
| Urea Nitrogen | 39 mg/dl | 41 mg/dl | -5.13% | 31 – 47 |
| Uric Acid | 6.9 mg/dl | 7 mg/dl | -1.45% | 5.6 - 8.4 |
| Cholesterol | 256 mg/dl | 263 mg/dl | -2.73% | 205 – 307 |
| HDL | 61 mg/dl | 59 mg/dl | 3.28% | 52 – 78 |
| Triglycerides | 241 mg/dl | 254 mg/dl | -5.39% | 187 – 281 |

The data supplied by the company substantiates their claim for a 28 day shelf life when stored unopened at 2 – 8 °C.

The company substantiated their claim for an opened, capped and refrigerated shelf life using real-time aging studies done at 4 °C. A summary of their findings for one example:

| Analyte | Initial Concentration | Concentration at 14 days | Percent Change | Concentration Range Accepted by Company |
| --- | --- | --- | --- | --- |
| Albumin | 5.5 g/dl | 5.5 g/dl | 0.00% | 4.5 - 6.7 |
| Alkaline Phosphatase | 430 U/L | 443 U/L | -3.02% | 345 - 517 |
| ALT | 217 U/L | 214 U/L | 1.38% | 184 - 275 |
| Amylase | 390 U/L | 390 U/L | 0.00% | 312 - 468 |
| AST | 134 U/L | 133 U/L | 0.75% | 98 - 146 |
| Bilirubin-total | 3.3 mg/dl | 3.3 mg/dl | 0.00% | 2.4 - 3.6 |
| Calcium-total | 11.5 mg/dl | 11.2 mg/dl | 2.61% | 10.0 - 15.0 |
| Chloride | 121 mEq/L | 121 mEq/L | 0.00% | 96 - 144 |
| LD | 187 U/L | 190 U/L | -1.60% | 149 - 225 |
| CK | 771 U/L | 792 U/L | -2.72% | 616 - 926 |
| Creatinine | 1.5 mg/dl | 1.5 mg/dl | 0.00% | 1.3 - 1.9 |
| GGT | 79 U/L | 80 U/L | -1.27% | 63 - 95 |
| Glucose | 177 mg/dl | 184 mg/dl | -3.95% | 138 - 206 |
| Magnesium | 3 mg/dl | 2.8 mg/dl | 6.67% | 2.5 - 3.7 |
| Phosphorus | 5.7 mg/dl | 5.9 mg/dl | -3.51% | 5.0 - 7.4 |
| Potassium | 4.9 mEq/L | 4.9 mEq/L | 0.00% | 4.5 - 6.7 |
| Protein-total | 8.9 g/dl | 8.7 g/dl | 2.25% | 7.0 - 10.6 |

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| Analyte | Initial Concentration | Concentration at 14 days | Percent Change | Concentration Range Accepted by Company |
| --- | --- | --- | --- | --- |
| Sodium | 166 mEq/L | 166 mEq/L | 0.00% | 136 - 204 |
| Urea Nitrogen | 39 mg/dl | 39 mg/dl | 0.00% | 31 - 47 |
| Uric Acid | 6.9 mg/dl | 6.8 mg/dl | 1.45% | 5.6 - 8.4 |
| Cholesterol | 256 mg/dl | 248 mg/dl | 3.13% | 205 - 307 |
| HDL | 61 mg/dl | 64 mg/dl | -4.92% | 52 - 78 |
| Triglycerides | 241 mg/dl | 242 mg/dl | -0.41% | 187 - 281 |

The data supplied by the company substantiates their claim for a 14 day shelf life when stored opened but capped at 2 – 8 °C.

d. Detection limit:

Not applicable for a device of this type.

e. Analytical specificity:

Not applicable for a device of this type.

f. Assay cut-off:

Not applicable for a device of this type.

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable for a device of this type.

b. Matrix comparison:

Not applicable for a device of this type.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable for a device of this type.

b. Clinical specificity:

Not applicable for a device of this type.

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

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Not applicable for a device of this type.

4. Clinical cut-off:
Not applicable for a device of this type.

5. Expected values/Reference range:
Not applicable for a device of this type.

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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