DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL
K962630 · Casco Standards · JJY · Jul 22, 1996 · Clinical Chemistry
Device Facts
| Record ID | K962630 |
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| Device Name | DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL |
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| Applicant | Casco Standards |
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| Product Code | JJY · Clinical Chemistry |
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| Decision Date | Jul 22, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 862.1660 |
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| Device Class | Class 1 |
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Intended Use
This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of clinical chemistry systems using methods for the quantitative measurement of ammonia, ethanol, and lactate. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
Device Story
DOCUMENT® Ammonia, Ethanol, Lactate Assayed Control is an aqueous-based liquid control product; provided in three levels. Used in clinical chemistry laboratories to monitor performance of automated, semi-automated, and manual testing systems. Functions as a quality control material to assess accuracy and precision of quantitative measurements for ammonia, ethanol, and lactate. Assists clinicians and laboratory technicians in troubleshooting system performance, reagent issues, and calibration anomalies. Provides necessary documentation for regulatory inspection agencies. Product is stored at 2° to 8°C and packaged in plastic containers with dropper tips.
Clinical Evidence
Bench testing only. Equivalence established by comparing inter-assay precision of ammonia, ethanol, and lactate measurements against predicate devices. Results indicate the subject device behaves in a similar manner to predicates and is suitable for its intended use as a control.
Technological Characteristics
Aqueous matrix control; three levels; packaged in plastic containers with dropper tips. Storage at 2° to 8°C. No electronic, software, or energy-based components.
Indications for Use
Indicated for use as an in vitro diagnostic control material to monitor the analytical performance, accuracy, and precision of clinical chemistry systems measuring ammonia, ethanol, and lactate levels in laboratory settings.
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
- CASCO DOCUMENT® Ammonia/Ethanol (Protein-Based) Controls (P-110, P-111, P-112)
- Bio-Rad Liquichek Unassayed Chemistry Control (Human) (16030)
Related Devices
- K140393 — RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 · Randox Laboratories Limited · Mar 25, 2014
- K123198 — LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA · Bio-Rad Laboratories · Nov 20, 2012
- K962629 — DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR · Casco Standards · Sep 13, 1996
- K981436 — DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 · Casco Standards · Apr 24, 1998
- K984225 — LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 · Bio-Rad · Dec 14, 1998
Submission Summary (Full Text)
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Exhibit 21. 510(k) Summary
962630
JUL 22 1996
# FEDERAL FOOD, DRUG AND COSMETIC ACT
## 510(k) SUMMARY
### DOCUMENT® Ammonia, Ethanol, Lactate Assayed Control, Levels I, II, III
1. Submitted by: CASCO Standards
P.O. Box 970
Yarmouth, ME 04096
Attention: Christine V. Beach
Manager, Regulatory Affairs
(207) 878-7550
(207) 878-7578 FAX
2. Product Name:
Proprietary Name: DOCUMENT® Ammonia, Ethanol, Lactate Assayed Control
Classification Name: Control, multiple analyte, assayed.
3. Predicate Device:
Product: CASCO DOCUMENT® Ammonia/Ethanol (Protein-Based) Controls
Catalog: LOW (P-110); MID (P-111), HIGH (P-112)
Manufacturer: CASCO Standards, Portland, ME
Analytes: Ammonia, Ethanol
Product: Bio-Rad Liquichek Unassayed Chemistry Control (Human), Levels 1 and 2
Catalog: 16030
Manufacturer: Bio-Rad, ECS Division, Anaheim, CA 28506
Analytes: Lactate
4. Product Description: DOCUMENT® Ammonia, Ethanol, Lactate Assayed Controls consist of three levels of an aqueous matrix containing ammonia, ethanol, and lactate. The formulation design provides a liquid matrix intended for use on automated, semi-automated, and manual clinical chemistry systems for the determination of ammonia (AMM), ethanol (ALC), and lactate (LAC).
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# 5. Intended Use:
This product is intended for *in vitro* diagnostic use as a control product to assess the analytical performance of clinical chemistry systems using methods for the quantitative measurement of ammonia, ethanol, and lactate. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
# 6. Comparison to the Predicate Device:
| Characteristic | DOCUMENT
Ammonia, Ethanol, Lactate
Assayed Control | DOCUMENT
Ammonia/Ethanol
(Protein-Based) Liquid Control | Bio-Rad Liquichek
Unassayed Chemistry Control |
| --- | --- | --- | --- |
| Part Number | P-114 / P-115 / P-116 | P-110 / P-111 / P-112 | 691 / 692 |
| Intended Use | Intended for *in vitro* diagnostic use as an assayed control on automated, semi-automated and manual clinical chemistry systems quantifying Ammonia, Ethanol, and Lactate. | Intended for *in vitro* diagnostic use as an indicator of analytical performance of systems quantifying Ammonia or Ethanol. This material is intended to serve as an assayed control material to aid in the assessment of day-to-day performance of such automated, semi-automated, and manual chemistry systems. | Intended for use as an unassayed quality control serum to monitor the accuracy and precision of an individual laboratory's automated and manual testing procedures. |
| Number of Levels | 3 | 3 | 2 |
| Type | Assayed | Assayed | Unassayed |
| Analytes | 3 | 2 | Many |
| Volume | 4 mL | 3 mL | 5 mL |
| Matrix | Aqueous | Bovine Base, Liquid | Human serum, Liquid |
| Bulk Storage | 2° to 8°C | -10° to -20°C | -10° to -20°C |
| Unopened Stability | Until Expiration Date | Until Expiration Date | Until Expiration Date |
| Open Storage | 2° to 8°C | 2° to 8°C | 2° to 8°C |
| Open Stability | 30 Days | 30 Days | 15 Days |
| Container | Plastic, Dropper Tip | Glass | Glass |
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# 7. Test Results:
The equivalence for this product was carried out by comparing the inter-assay precision of the listed analytes of the DOCUMENT®Ammonia, Ethanol, Lactate Assayed Control to that of CASCO DOCUMENT®Ammonia/Ethanol (Protein-Based) Controls and Bio-Rad Liquichek Unassayed Chemistry Controls. The results show that the DOCUMENT®Ammonia, Ethanol, Lactate Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes.
