(70 days)
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No
The device is a calibrator for clinical chemistry systems and the description focuses on its chemical composition and intended use for quantitative calibration, with no mention of AI or ML.
No.
This device is a calibrator for in vitro diagnostic use, intended to provide quantitative calibration for clinical chemistry systems. It is not used for direct treatment or diagnosis of a patient.
No
The device is described as a "Calibrator" intended for "quantitative calibration of automated, semi-automated, or manual clinical chemistry systems" used for the measurement of specific substances (ammonia, ethanol, lactate). It is used to calibrate diagnostic devices, not to perform diagnosis itself.
No
The device description clearly 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/Indications for Use: The document explicitly states the device 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." This directly aligns with the definition of an IVD, which is a medical device used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description further clarifies that the calibrators are used for the "quantitative determination of ammonia (AMM), ethanol (ALC) and lactate (LAC)" on clinical chemistry systems. This reinforces its role in diagnostic testing.
- Performance Studies: The performance studies describe comparing the calibrator to predicate devices using patient samples and analyzing quantitative analytical recovery. This is typical for validating an IVD used in clinical settings.
The document clearly indicates that this device is used outside of the body (in vitro) to calibrate instruments that measure substances in human specimens for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes
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Device 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).
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1150 Calibrator.
(a)
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.)(b)
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.
0
SEP 13 1996
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 6, 2, 6, 2, and 9. The numbers are written in a bold, slightly irregular style, giving them a hand-drawn appearance. The black ink contrasts sharply with the white background, making the characters stand out.
Exhibit 21. 510(k) Summary
FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY
DOCUMENI® Ammonia, Ethanol, Lactate Calibrator, 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:
Proprietary Name: DOCUMENI® Ammonia, Ethanol, Lactate Calibrator
- Product Name:
Classification Name: Control, multiple analyte, assayed.
1
- 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, 100umol/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
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- 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).
-
- 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.
2
K962629
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- Comparison to the Predicate Device:
| Characteristic | DOCUMENI®
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 |
3
- 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.