DC-ACETA/SAL CONTROLS

K041666 · Diagnostic Chemicals , Ltd. · DIF · Aug 17, 2004 · Clinical Toxicology

Device Facts

• Record ID: K041666
• Device Name: DC-ACETA/SAL CONTROLS
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Aug 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

The intended use of the DC-Aceta/Sal is for in vitro diagnostic use in quality control procedures to monitor the accuracy and precision of manual and automated acetaminophen and salicylate assays. The DC Aceta/Sal Control, Cat. Nos. SE-008/SE-010 is intended for in vitro use in quality control procedures to monitor the accuracy and precision of manual and automated acetaminophen and salicylate assays.

Device Story

DC-Aceta/Sal is a lyophilized bovine albumin-based control material containing acetaminophen and salicylate; used in clinical laboratories to monitor accuracy and precision of manual and automated toxicology assays. Provided in two levels: Level 1 (sub-toxic concentrations) and Level 2 (near-toxic concentrations). Reconstituted with deionized or distilled water. Healthcare providers use the assayed values to verify performance of diagnostic test systems; ensures reliability of patient test results for acetaminophen and salicylate levels.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized bovine albumin matrix containing acetaminophen and salicylate. Kit includes 6 x 3 mL vials with rubber stoppers and seals. Storage at 2–8 °C. Stability: 7 days post-reconstitution at 2–8 °C.

Indications for Use

Indicated for in vitro diagnostic use as a quality control material to monitor the accuracy and precision of manual and automated acetaminophen and salicylate assays in clinical laboratory settings.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Submission Summary (Full Text)

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

A. 510(k) Number: k041666
B. Purpose of Submission: Premarket Notification Abbreviated [510(k)] of intention to manufacture and market the DC-Acetaminophen/ Salicylate Controls.
C. Analyte: Acetaminophen and salicylate
D. Type of Test: NA
E. Applicant: Diagnostic Chemicals Limited
F. Proprietary and Established Names: DC Aceta/Sal Control Set, Cat. Nos. SE-008/SE-010
G. Regulatory Information:
1. Regulation section: 21 CFR §862.3280 – clinical toxicology control material
2. Classification: Class I
3. Product Code: DIF
4. Panel: 91

H. Intended Use:
1. Intended use(s):
The intended use of the DC-Aceta/Sal is for in vitro diagnostic use in quality control procedures to monitor the accuracy and precision of manual and automated acetaminophen and salicylate assays.
2. Indication(s) for use:
The DC Aceta/Sal Control, Cat. Nos. SE-008/SE-010 is intended for in vitro use in quality control procedures to monitor the accuracy and precision of manual and automated acetaminophen and salicylate assays.
3. Special condition for use statement(s): For prescription use.
4. Special instrument Requirements: The intended instruments are stated in the package insert.

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I. Device Description: The DC-Aceta/Sal is a lyophilized preparation of bovine albumin, acetaminophen and salicylate. It is presented in a Level 1 or Level 2 kit format with assayed values published for each lot. Each kit is a cardboard box containing 6 x 3 mL brown serum vials with rubber stoppers and plastic/aluminum seals, appropriate labels and a product insert.

The level one assayed control is Catalog Number SE-008 and the acetaminophen and salicylate values are below the toxic concentration. The level two assayed control is Catalog Number SE-010 and the acetaminophen and salicylate values are at or near the toxic concentration.

J. Substantial Equivalence Information:

1. Predicate device name(s): Lyphocheck Immunoassay Plus Control
3. Predicate k number(s): k981532
4. Comparison with predicate:

| ATTRIBUTE | ACETA/SAL | LYPHOCHEK |
| --- | --- | --- |
| Size | 6x3 mL | 12x5 mL |
| Format | Lyophilized | Lyophilized |
| Intended Use | To monitor accuracy & precision of assays | To monitor precision of assays |
| Reconstitution | Add 3 mL deionized or distilled water | Add 5 mL deionized or distilled water |
| Source of Base | Bovine Serum | Human Serum |
| Stability | 7 days, after reconstitution at 2 – 8 °C | 7 days, after reconstitution at 2 – 8 °C |
| Storage Temperature | 2 – 8 °C | 2 – 8 °C |
| Acetaminophen | Yes | Yes |
| Salicylate | Yes | Yes |
| Value Assignment | Lot Specific | Lot Specific |
| Range of Values | Level 1 and 2 | Level 1, 2, and 3 |

K. Standard/Guidance Document Referenced (if applicable): None referenced

L. Test Principle: NA

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: NA

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b. Linearity/assay reportable range: NA
c. Traceability (controls, calibrators, or method):

The constituents of DC Aceta/Sal are the drug compounds acetaminophen and salicylate. These are purchased as bulk chemicals from pre-approved vendors. Values are assigned using 20 vials of each control and the appropriate Diagnostic Chemicals Limited reagent on two different types of analyzers. The value assignment for Acetaminophen is obtained by averaging values from the two different assay methodologies. The value assignment for Salicylate is obtained from a single assay methodology.

Open vial stability of the DC Aceta/Sal controls was assessed at day 1 and 7 on control stored at normal storage temperature and at accelerated temperature. The assay reagents were considered stable to 14 days, if there was $\pm 10\%$ deviation from day 0 results.

Long term real time stability studies were performed and run one month past stated stability.

c. Detection limit: NA
d. Analytical specificity: NA
e. Assay cut-off: NA

2. Comparison studies:
a. Method comparison with predicate device: NA
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

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