VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901

K062501 · Maine Standards Co. · JJX · Sep 29, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062501
• Device Name: VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
• Applicant: Maine Standards Co.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in chemistry systems for the following analytes: Triodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol. VALIDATE Thyroid Calibration Verification Test Set solutions are not intended for use as routine quality control materials or as calibration materials.

Device Story

VALIDATE Thyroid Calibration Verification Test Set consists of six levels of human serum-based solutions containing T3, T4, human TSH, and Cortisol. Used in clinical chemistry laboratories to verify the linearity and reportable range of automated, semi-automated, or manual chemistry systems. Clinicians or laboratory technicians use the test set to compare theoretical values against actual system performance. This verification ensures the accuracy of patient diagnostic testing for thyroid function and cortisol levels.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria were reviewed and found acceptable. Traceability to NIST Standard Reference Materials (SRM) or primary analytical standards was established.

Technological Characteristics

Human serum-based matrix; multi-level (6 levels) liquid test set; 3.0 mL per bottle. Designed for in vitro diagnostic use in chemistry systems. No software or electronic components.

Indications for Use

Indicated for in vitro diagnostic use in clinical chemistry systems to verify linearity, calibration, and reportable ranges for T3, T4, TSH, and Cortisol. Prescription use only.

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.

Predicate Devices

• Thyroid CAL●VER (k992034)

Submission Summary (Full Text)

{0}

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

A. 510(k) Number:
k062501

B. Purpose for Submission:
New device

C. Measurand:
Calibration verification solutions for Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol.

D. Type of Test:
Calibration verification

E. Applicant:
Maine Standards Company

F. Proprietary and Established Names:
VALIDATE Thyroid Calibration Verification Test Set

G. Regulatory Information:
1. Regulation section:
21 CFR §862. 1660, Quality Control Material
2. Classification:
Class I
3. Product Code:
JJX
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
See Indications for Use
2. Indication(s) for use:
VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in chemistry systems for the

{1}

Page 2 of 4

following analytes: Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol.

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

4. Special instrument Requirements:
Automated, semi-automated, and manual clinical chemistry systems

I. Device Description:
VALIDATE Thyroid Calibration Verification Test Set contains T3, T4, human TSH, and Cortisol in human serum matrix. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes. Each test set consists of one bottle each of six (6) levels including zero. Each bottle of Levels 0 through 5 contains 3.0 milliliters. This material is stable until the date printed on the label when stored as directed.

All human source material was tested and found to be negative for HIV ½, HBsAg, and RPR by FDA approved methods.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Thyroid CAL●VER
2. Predicate K number(s):
k992034
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | For in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated semi-automated and manual chemistry systems | For in vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR), and verification of reportable ranges in automated semi-automated and manual chemistry systems |
| Matrix | Human serum | Human serum |
| Storage | -10 to -20°C | -10 to -20°C |

{2}

Page 3 of 4

K. Standard/Guidance Document Referenced (if applicable):
Not applicable

L. Test Principle:
Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability (controls, calibrators, or method):
VALIDATE Thyroid Calibration Verification Test Set solutions are tested during manufacturing with standards traceable to National Institute for Standards and Technology (NIST) Standard Reference Material (SRM) where available. For analytes where NIST materials are not available, primary analytical standards are used.

Stability testing protocols and acceptance criteria were described and found to be acceptable.

d. Detection limit:
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

{3}

Page 4 of 4

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:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and satisfies the requirement of 21 CFR part 809.10

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