(17 days)
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No
The summary describes a control product for clinical chemistry systems, focusing on analytical performance assessment and troubleshooting. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a control product for in vitro diagnostic use to assess the analytical performance of clinical chemistry systems, not to treat or modify a disease or condition in a patient.
No
The device is a control product used to assess the analytical performance of clinical chemistry systems, not to diagnose medical conditions in patients. It helps ensure the accuracy of diagnostic tests.
No
The device description explicitly states it is an "aqueous matrix containing ammonia, ethanol, and lactate," which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "This product is intended for in vitro diagnostic use".
- Purpose: It is used as a control product to assess the analytical performance of clinical chemistry systems, which are used for in vitro diagnostic testing.
- Matrix: The "Device Description" mentions an "aqueous matrix containing ammonia, ethanol, and lactate," which is a common format for in vitro diagnostic control materials.
- Analytes: The analytes being measured (ammonia, ethanol, and lactate) are substances typically measured in biological samples (like blood or urine) for diagnostic purposes.
- Setting: The intended user is described as "clinical chemistry systems," which are used in clinical laboratories for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
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Device 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).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The equivalence for this product was carried out by comparing the inter-assay precision of of the listed analytes of 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
CASCO DOCUMENT Ammonia/Ethanol (Protein-Based) Controls, Bio-Rad Liquichek Unassayed Chemistry Control (Human), Levels 1 and 2
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
962630
Jul 22 1996
FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY
DOCUMENI® Ammonia. Ethanol. Lactate Assayed Control, Levels I, III, III
-
- 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
-
- Product Name:
DOCUMENT® Ammonia, Ethanol, Lactate Assayed Control Proprietary Name:
Classification Name: Control, multiple analyte, assayed.
-
- 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 |
-
- 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).
1
-
- 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 | DOCUMENI
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 |
2
-
- Test Results: The equivalence for this product was carried out by comparing the inter-assay precision of of the listed analytes of of the DOCUMENI®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.