DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR

K962629 · Casco Standards · JIX · Sep 13, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962629
• Device Name: DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR
• Applicant: Casco Standards
• Product Code: JIX · Clinical Chemistry
• Decision Date: Sep 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended for in vitro diagnostic use for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems used for the measurement of ammonia, ethanol, and lactate. DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended to provide for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values included for the various analytical systems on which it was assayed.

Device Story

Aqueous liquid calibrator containing ammonia, ethanol, and lactate; used in clinical chemistry laboratories to calibrate automated, semi-automated, or manual analyzers. Provides lot-specific set point values for quantitative determination of analytes. Used by laboratory technicians to ensure accuracy of patient sample measurements. Benefits patient by ensuring reliable, standardized clinical chemistry results for ammonia, ethanol, and lactate.

Clinical Evidence

Bench testing only. Method comparison study performed per NCCLS EP9 protocol comparing quantitative analytical recovery of patient samples using subject calibrator versus predicate calibrators on Hitachi 717 and Beckman Synchron CX5 systems. Results indicate subject device behaves similarly to predicates and is suitable for intended use.

Technological Characteristics

Aqueous matrix calibrator; single level; contains ammonia, ethanol, and lactate; packaged in plastic containers with dropper tips. Stability: 30 days open. Traceable/Assigned values for analytes.

Indications for Use

Indicated for in vitro diagnostic use as a calibrator for automated, semi-automated, or manual clinical chemistry systems measuring ammonia, ethanol, and lactate levels in patient samples.

Regulatory Classification

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

• New England Reagent Laboratories Ammonia Standards (K962629)
• Beckman Instruments Alcohol Kit Calibrator (K962629)
• Beckman Instruments CX Multi Calibrator (K962629)

Submission Summary (Full Text)

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SEP 13 1996
K962629

Exhibit 21. 510(k) Summary

FEDERAL FOOD, DRUG AND COSMETIC ACT
510(k) SUMMARY

DOCUMENT® Ammonia, Ethanol, Lactate Calibrator, Levels I, II, III

1. Submitted by: CASCO Standards
P.O. Box 970
Yarmouth, ME 04096

Attention: Christine V. Beach
Manager, Regulatory Affairs
[phone]
[phone] FAX

2. Product Name:
Proprietary Name: DOCUMENT® Ammonia, Ethanol, Lactate Calibrator
Classification Name: Control, multiple analyte, assayed.

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K962629

3. Predicate Device:

Analyte: Ammonia
Manufacturer: Boehringer Mannheim Corp., Indianapolis, IN
System: Hitachi 717 System
Reagents: Boehringer Mannheim Corp., Ammonia, Kit No. 450055
Calibrator: New England Reagent Laboratories, East Providence, RI
Ammonia Standards, 100μmol/L, part of Kit No. NERL 1207

Analyte: Ethanol
Manufacturer: Beckman Instruments, Brea, CA
System: Beckman Synchron CX5
Reagents: Beckman Instruments, Alcohol, Kit No: 445900
Calibrator: Beckman Instruments, Fullerton, CA
Alcohol, part of Kit No. 445900

Analyte: Lactate
Manufacturer: Beckman Instruments, Brea, CA
System: Beckman Synchron CX5
Reagents: Beckman Instruments, Lactate, Kit No. 445875
Calibrator: Beckman Instruments, Fullerton, CA
Lactate, CX Multi Calibrator, Part No. 442600

4. Product Description:
DOCUMENT Ammonia, Ethanol, Lactate Calibrators consist of one level of an aqueous matrix containing ammonia, ethanol, and lactate. The formulation design provides a liquid calibrator intended for use on automated, semi-automated, and manual clinical chemistry systems for the quantitative determination of ammonia (AMM), ethanol (ALC) and lactate (LAC).

5. Intended Use:
DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended for in vitro diagnostic use for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems used for the measurement of ammonia, ethanol, and lactate. DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended to provide for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values included for the various analytical systems on which it was assayed.

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6. Comparison to the Predicate Device:

| Characteristic | DOCUMENT®
Ammonia, Ethanol, Lactate Calibrator | New England Reagent Laboratory Ammonia Standards | Beckman Alcohol Kit Calibrator | Beckman CX Multi Calibrator |
| --- | --- | --- | --- | --- |
| Intended Use | Intended for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. | None given | Intended for the quantitative determination of alcohol concentration in serum or plasma on SYNCHRON CX Systems | Intended for use on the SYNCHRON CX Systems for the calibration of ..., Lactate, ... |
| Number of Levels | One | Five | One | One |
| Type | Traceable: Ammonia Ethanol Assigned: Lactate | Assigned | Assigned | Assigned |
| Analytes | 3 | 1 | 1 | Many |
| Volume | 4 mL | 5 mL | 5 mL | 20 mL |
| Matrix | Aqueous | Aqueous | Aqueous | Human serum, Liquid |
| Dilution | None required | None required | None required | None required |
| Unopened Stability | Until Expiration Date | Until Expiration Date | Until Expiration Date | Until Expiration Date |
| Open Stability | 30 Days | None indicated | 7 Days | 20 Days |
| Container | Plastic, Dropper Tip | Plastic, Dropper Tip | Plastic, Dropper Tip | Plastic, Dropper Tip |

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## 7. Test Results:

The equivalence for this product was carried out by comparing quantitative analytical recovery of patient samples using the NCCLS EP9 Protocol: *Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline*. The DOCUMENT Ammonia, Ethanol, Lactate Calibrator was compared to the NERL 100μmol/L Ammonia Standard using BMC Ammonia reagents on a Hitachi 717 Clinical Chemistry Analyzer, the Beckman Alcohol Kit Calibrator with Beckman Reagents on a Beckman Synchron CX5 System, and the Beckman CX Multi Calibrator using Beckman Lactate reagent on a Beckman Synchron CX5 System. The results show that the DOCUMENT Ammonia, Ethanol, Lactate Calibrator behaves in a similar manner compared to the predicate devices and is suitable for use as a calibrator for the listed analytes on those systems tested.

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