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The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.

The Indiko Glucose (HK) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Device Description

The Indiko is automated random access discrete photometric analyzer, capable of performing up to 30 photometric tests.

The sample disk has an integrated barcode reader which allows cup/tube recognition. The barcode reader can read the following codes: code 128, USS Codabar, interleaved 2 of 5 and code 39 with check digit.

Reaction cells are discrete disposable (single use) multicell cuvettes with 10 reaction measurement cells in a row. On-board capacity of 36 multicell cuvettes (equal to 360 reaction cells), with continuous loading capability, typically 2 hours walk-away time. The quality of the reaction cells is checked at the start of the routine work automatically. The measurements are performed at 37℃.

The analyzer incorporates robotics, computer, and communication technology to render simple and reliable long-term operation. The operating system works with Windows® 7. The user interface software is graphical. The data input can be done online or by touch screen or mouse or keyboard.

Reagents are liquid, the reagent bottles are placed on the reagent/sample disk, which holds maximum 30 positions, the reagent/sample disk is cooled 10℃ below ambient temperature.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Indiko Glucose (HK) system, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance	Performance Accepted
Method Comparison	y = ax + b, where a = 1.00 ± 0.03, b = 0.00 ± 3.6 mg/dl, r ≥ 0.97, max bias at 90 mg/dl 5%	y = 1.01x + 0.7, r = 1, Range: 6 - 700 mg/dl	Yes
Precision (Within run)	Low: CV ≤ 2.0 %
Middle: CV ≤ 2.0 %
High: CV ≤ 1.8 %	Low: CV 0.7 %
Middle: CV 0.6 %
High: CV 0.8 %	Yes
Precision (Between run)	Not specified	Low: CV 0.8 %
Middle: CV 1.2 %
High: CV 0.6 %	Yes
Precision (Total)	Low: CV ≤ 3.5 %
Middle: CV ≤ 3.5 %
High: CV ≤ 3.0 %	Low: CV 1.6 %
Middle: CV 1.5 %
High: CV 1.5 %	Yes
Linearity/Measuring Range	Measuring range: 5 - 720 mg/dl
Maximum bias from the estimated straight line ± 2.7 mg/dl or ± 5 %.	Measuring range: 5 - 720 mg/dl	Yes
Limit of Blank (LoB)	LoB:

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K Number

K073295

Device Name

UREA/BUN, SCAL, NORTROL, ABTROL

Manufacturer

THERMO FISHER SCIENTIFIC OY

Date Cleared

2008-05-29

(188 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K991576

Intended Use

The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Device Description

The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma.

sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet.

Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet.

AI/ML Overview

The provided text describes the 510(k) summary for the Thermo Fisher Scientific Oy Urea/BUN, sCal, Nortrol, and Abtrol devices. The information provided focuses on demonstrating substantial equivalence to a predicate device (Bayer ADVIA 2400 Chemistry System) for laboratory diagnostic tests.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparative table (Table 1) between the new device and the predicate device for several attributes. However, it does not explicitly state pre-defined acceptance criteria (e.g., "The new device's precision must be within X% of the predicate device"). Instead, it presents the performance data for both devices, implying that the new device's performance is deemed acceptable if it is comparable to the predicate device.

Table 1: Comparison of New Device (Urea / BUN) and Predicate Device (Bayer ADVIA Urea Nitrogen (UN) assay)

Attribute	New device #1 Reported Performance (Urea Nitrogen mg/dL)	Predicate device #1 Reported Performance (Urea Nitrogen mg/dL)
Intended Use	For in vitro diagnostic use in the quantitative determination of Urea / BUN (urea nitrogen) concentration in human serum or plasma on T60 instrument.	For in vitro diagnostic use in the quantitative determination of urea nitrogen in human serum, plasma (lithium heparin), and urine on the ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of kidney disease, urinary tract obstruction, and acute or chronic renal failure.
Indication for Use	Intended for quantitative in vitro diagnostic measurement of urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.	See intended use.
Assay Protocol	Urea is hydrolysed to produce ammonia and carbon dioxide. Ammonia combines with α-ketoglutarate (α-KG) and NADH in the presence of GLDH to produce L-glutamate. Decrease in absorbance at 340 nm is proportional to urea level.	Urea is hydrolyzed to produce ammonia and carbon dioxide. Ammonia reacts with 2-oxoglutarate in the presence of glutamate dehydrogenase and NADH. Oxidation of NADH to NAD is measured as an inverse rate reaction at 340/410 nm.
Traceability/Standardization	Value assigned using NIST SRM 909b as a primary reference.	Traceable to the CDC reference method, which uses reference materials from NIST via patient sample correlation.
Sample Type	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin) and urine
Reagent Storage	Unopened vials stable at 2...8 °C until expiration date.	Unopened reagents stable until expiration date when stored at 2°-8°C. Do not freeze reagents.
Expected Values	Serum, adult: Urea Nitrogen: 6 - 20 mg/dl (2.2 - 7.2 mmol/l); Urea: 13 - 43 mg/dl (2.2 - 7.2 mmol/l)	Serum: 9 - 23 mg/dL (3.2 – 8.2 mmol/L); Urine: 12 – 20 g/day (0.43 – 0.71 mol/day)
Instrument	T60 and DPC T60i, DPC T60i Kusti	ADVIA® 2400 Chemistry system.
Measuring Range	Serum: Urea nitrogen: 4.2 - 56 mg/dl (1.5 - 20.0 mmol/l); Urea: 9 - 120 mg/dl (1.5 - 20.0 mmol/l)	Serum: 5 - 150 mg/dL (1.8 – 53.6 mmol/L); Urine: 35 - 1000 mg/dL (12.5 - 357 mmol/L)
Precision	Within run:
Level 5.7 mg/dL: SD=0.2, CV(%)= 3.1
Level 14.7 mg/dL: SD=0.2, CV(%)= 1.4
Level 24.7 mg/dL: SD=0.4, CV(%)= 1.7
Level 44.8 mg/dL: SD=0.4, CV(%)= 0.8
Between run:
Level 5.7 mg/dL: SD=0.4, CV(%)= 7.4
Level 14.7 mg/dL: SD=0.1, CV(%)= 1.0
Level 24.7 mg/dL: SD=0.4, CV(%)= 1.8
Level 44.8 mg/dL: SD=0.4, CV(%)= 1.0
Total:
Level 5.7 mg/dL: SD=0.5, CV(%)= 8.1
Level 14.7 mg/dL: SD=0.4, CV(%)= 2.7
Level 24.7 mg/dL: SD=0.9, CV(%)= 3.6
Level 44.8 mg/dL: SD= 1.0, CV(%)= 2.2	Serum: Within run:
Level 19 mg/dL: SD=0.3, CV(%)= 1.4
Level 67 mg/dL: SD=0.3, CV(%)= 0.5
Level 81 mg/dL: SD=0.5, CV(%)=0.7
Total:
Level 19 mg/dL: SD=0.4, CV(%)= 2.2
Level 67 mg/dL: SD= 1.0, CV(%)= 1.5
Level 81 mg/dL: SD= 1.3, CV(%)= 1.6
Urine: Within run:
Level 453 mg/dL: SD=10.1, CV(%)= 2.2
Level 712 mg/dL: SD=28.6, CV(%)= 4.0
Total:
Level 453 mg/dL: SD= 15.2, CV(%)= 3.4
Level 712 mg/dL: SD= 30.6, CV(%)= 4.3
Method Comparison	Comparison to Bayer ADVIA 2400:
y = 0.94x + 0.25
R = 0.996
range from 4.3 to 117.3 mg/dL
N = 143	Serum: ADVIA 1650:
y = 1.01x + 0.0, r = 1.000, N = 229, Range 5.1 -146.8 mg/dL
Reference Method:
y = 1.04x - 0.1, r = 0.997, N = 50, Range 5.5-136.2 mg/dL
Urine: ADVIA 1650:
y = 0.95x + 2.3, 0.995, N = 51, Range 76.0 - 982.0 mg/dL
Limitations	Lipemia: No interference up to 1000 mg/dL (10 g/l) Intralipid.
Hemolysate: No interference up to 1000 mg/dl (10 g/l) hemoglobin.
Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l).
Bilirubin, unconjugated: No interference up to 58 mg/dL (1000 µmol/l).	Lipemia (from Intralipid): No significant interference up to 625 mg/dl of Intralipid.
Hemolysate: No significant interference up to 525 mg/dl of hemoglobin.
Bilirubin: No significant interference up to 30 mg/dl.

Study Details to Prove Acceptance: Method Comparison Study

The primary study mentioned to demonstrate substantial equivalence and meet implied acceptance criteria is a method comparison study against the predicate device.

Acceptance Criteria (Implied): The new device's results should correlate strongly with the predicate device, demonstrated by a regression equation (y = mx + b) where 'm' is close to 1, 'b' is close to 0, and the correlation coefficient 'R' (or 'r') is close to 1. Limitations should also be comparable or better.
Study Description (New Device):
- Method Comparison: Comparison to Bayer ADVIA 2400.
- Regression Equation: y = 0.94x + 0.25 (where y is the new device and x is the predicate device).
- Correlation Coefficient: R = 0.996.
- Range: From 4.3 to 117.3 mg/dL.
- Sample Size: N = 143.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
- Types of Ground Truth: Not applicable in the traditional sense of expert consensus for imaging, as this is a quantitative chemical assay. The "ground truth" for the comparison is the measurement result from the predicate device (Bayer ADVIA 2400), which itself is established using a CDC reference method traceable to NIST materials.
- Training Set Sample Size & Ground Truth: Not applicable to this type of method comparison study for quantitative diagnostic devices. These devices are typically analytical rather than AI/machine learning driven, so "training sets" in that context are not relevant here.

Regarding other specific questions, based on the provided text:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: N = 143 for the method comparison study.
- Data Provenance: Not explicitly provided (e.g., country of origin, retrospective or prospective nature of the samples).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For quantitative diagnostic assays like Urea/BUN, "ground truth" is typically established by reference methods or highly accurate analytical techniques, not by human expert consensus as might be the case for image-based diagnostics. The predicate device's results serve as the comparison point, traceable to NIST standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of quantitative diagnostic device. Adjudication methods are typically relevant for subjective assessments, like interpreting medical images.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. This is a comparison between two quantitative diagnostic devices (the new device and a predicate device). MRMC studies are specific to evaluating human reader performance, often with and without AI assistance, typically in image interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself (Urea/BUN assay on the T60 instrument) operates in a standalone manner to produce a quantitative result. The method comparison study evaluates this standalone analytical performance against a comparator device. There is no "human-in-the-loop" aspect described for the assay's primary function.
The type of ground truth used: The ground truth for the comparison is the measurement obtained from the predicate device (Bayer ADVIA 2400), which itself is stated to be traceable to the CDC reference method and uses NIST reference materials. This indicates a high-level analytical standard as the basis for comparison.
The sample size for the training set: Not applicable for this type of device and study. These are chemical assays, not AI algorithms requiring a "training set" in the machine learning sense.
How the ground truth for the training set was established: Not applicable, as there is no "training set" in the context of an AI algorithm described here.

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K Number

K073612

Device Name

URIC ACID (AOX), SCAL, NORTROL, ABTROL

Manufacturer

THERMO FISHER SCIENTIFIC OY

Date Cleared

2008-05-23

(154 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K991576

Intended Use

The Uric Acid (AOX) test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout.

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy

Device Description

Not Found

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Uric Acid (AOX) device based on the provided 510(k) summary:

This device is an IVD (In Vitro Diagnostic) and the criteria and performance metrics are related to analytical performance, not clinical performance metrics typical of AI/ML devices for diagnostic imaging studies. Therefore, many of the requested fields for AI/ML studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device K991576)	Reported Device Performance (Uric Acid (AOX))
Measuring Range	Serum: 0 - 20 mg/dL	Serum: 0.2 - 20.0 mg/dl (10 - 1200 µmol/l)
	Urine: 0 - 180 mg/dL	Not applicable (device does not test urine)
Precision	Within Run:	Within Run:
	Level 3.9 mg/dL: CV(%) = 1.1	Level 1.2 mg/dL: CV(%) = 0.8
	Level 8.6 mg/dL: CV(%) = 1.1	Level 2.3 mg/dL: CV(%) = 0.7
	Level 10.0 mg/dL: CV(%) = 0.6	Level 4.4 mg/dL: CV(%) = 0.7
		Level 8.9 mg/dL: CV(%) = 0.5
	Total Precision:	Between Run:
	Level 3.9 mg/dL: CV(%) = 1.9	Level 1.2 mg/dL: CV(%) = 1.3
	Level 8.6 mg/dL: CV(%) = 1.6	Level 2.3 mg/dL: CV(%) = 0.9
	Level 10.0 mg/dL: CV(%) = 2.3	Level 4.4 mg/dL: CV(%) = 0.7
		Level 8.9 mg/dL: CV(%) = 0.4
		Total Precision:
		Level 1.2 mg/dL: CV(%) = 2.3
		Level 2.3 mg/dL: CV(%) = 1.7
		Level 4.4 mg/dL: CV(%) = 2.8
		Level 8.9 mg/dL: CV(%) = 1.1
Method Comparison	Comparison to Technicon DAX: r = 0.994	Comparison to Bayer ADVIA 2400: R = 0.999
	Range: 0.2 - 18.0 mg/dL	Range: 0.3 to 12.6 mg/dL
	N = 154	N = 105
	Comparison to Reference Method: r = 0.999
	Range: 1.7 - 19.5 mg/dL
	N = 49
Limitations	Hemolysate: No significant interference up	Lipemia: No interference up to 900 mg/dl
	to 525 mg/dl of hemoglobin	Hemolysate: No interference up to 1000 mg/dl of hemoglobin
	Bilirubin: No significant interference up	Bilirubin conjugated: No interference up
	to 30 mg/dl	to 11 mg/dl
	Triglycerides: Effect measured	Bilirubin total: No interference up to
		14 mg/dl

Note: The acceptance criteria for the new device are implicitly demonstrated by showing comparable or better performance relative to the predicate device across the various analytical performance characteristics. The document doesn't explicitly state "acceptance criteria" but rather presents a comparison to the predicate, implying that performance similar to or better than the predicate is considered acceptable.

2. Sample Size Used for the Test Set and Data Provenance

Method Comparison (Linearity/Correlation): N = 105 human serum/plasma samples (range 0.3 to 12.6 mg/dL).
Precision: Not explicitly stated as "sample size" but rather "levels" tested (e.g., Level 1.2 mg/dL, 2.3 mg/dL, 4.4 mg/dL, 8.9 mg/dL) with corresponding SD and CV values. Typically, precision studies involve multiple replicates of control or patient samples.
Limitations (Interference): Specific concentrations of interfering substances (Intralipid, hemoglobin, conjugated bilirubin, unconjugated bilirubin) were tested. The number of samples for each interference test is not explicitly stated.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "human serum or plasma" samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for an in vitro diagnostic (IVD) device that quantifies a biomarker (uric acid) using chemical reactions on an instrument. The "ground truth" for the test set is established by comparative measurements against a legally marketed predicate device (Bayer ADVIA 2400) and/or reference methods, not by expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. See explanation for #3. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic decisions (e.g., in medical imaging).

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done

No. This is an IVD device for quantitative measurement, not a diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC study is not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, effectively. The performance data presented (measuring range, precision, method comparison, limitations) are measurements of the device's analytical performance on its own (algorithm/reagent/instrument combination) without human qualitative interpretation being a variable. The device provides a quantitative measurement, and its accuracy and precision are assessed directly.

7. The Type of Ground Truth Used

Comparative Measurement to a Predicate Device and Traceability to a Primary Reference (NIST SRM 909b).
- Method Comparison: The device's results were compared to the Bayer ADVIA 2400 Chemistry System, which serves as a widely accepted "ground truth" for method comparison in IVD submissions.
- Traceability/Standardization: The value of Uric Acid (AOX) is stated to be assigned using NIST SRM 909b as a primary reference. The predicate device also establishes traceability to the CDC candidate reference method, which uses NIST reference materials. This indicates a strong chain of traceability to established analytical standards for ground truth.

8. The Sample Size for the Training Set

Not explicitly stated/applicable in the context of this traditional IVD. Traditional IVDs like this do not typically use "training sets" in the same way machine learning algorithms do. The development process involves optimizing the reagent formulation and instrument parameters, which is an iterative process, but not framed as "training" with a specific data set.

9. How the Ground Truth for the Training Set Was Established

Not explicitly stated/applicable. As mentioned above, the concept of a "training set" and establishing ground truth for it is not directly transferable to the development of this type of IVD device. The development relies on principles of analytical chemistry, reagent formulation, and instrument engineering to achieve accurate and precise measurements traceable to established standards.

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K Number

K073355

Device Name

CALCIUM, SCAL, NORTROL, ABTROL

Manufacturer

THERMO FISHER SCIENTIFIC OY

Date Cleared

2008-02-28

(91 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K991576

Intended Use

The Calcium test system is intended for in vitro diagnostic use in the quantitative determination of the calcium concentration in human serum or plasma on T60 instruments. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

Device Description

Not Found

AI/ML Overview

The provided text describes the Thermo Fisher Scientific Calcium Test System (Calcium, sCal, Nortrol, Abtrol) and its substantial equivalence to a predicate device, the Bayer ADVIA Calcium assay. The information largely focuses on comparing performance metrics between the new device and the predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, structured according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a set of pre-defined thresholds the new device had to meet. Instead, it presents a comparison table (Table 1) of various performance attributes between the new device (Calcium) and the predicate device (Bayer ADVIA Calcium assay). The implicit "acceptance" is that the new device's performance is substantially equivalent to or better than the predicate's.

Attribute	Acceptance Criteria (Implicit - based on predicate)	New Device Performance (Calcium)	Predicate Device Performance (Bayer ADVIA Calcium assay)
Intended Use	Similar quantitative determination of calcium in human serum/plasma	For quantitative determination of calcium in human serum or plasma on T60 instruments.	For quantitative determination of calcium in human serum, plasma (lithium heparin), and urine on ADVIA Chemistry systems.
Indication for Use	Similar diagnostic and treatment uses for parathyroid disease, bone diseases, renal disease, and tetany	Diagnosis and treatment of parathyroid disease, bone diseases, chronic renal disease and tetany.	Same as intended use.
Assay Protocol	Comparable method for calcium detection	Calcium ions form a highly coloured complex with Arsenazo III at neutral pH, measured at 660 nm.	Calcium ions form a violet complex with o-cresolphthalein complexone in an alkaline medium, measured at 545/658 nm.
Traceability/ Standardization	Traceable to recognized standard	NIST SRM 909b as a primary reference.	Traceable to a NIST atomic absorption reference method, using NIST reference materials via patient sample correlation.
Sample Type	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin) and urine.
Reagent Storage	Stable under specified conditions	2-25°C until expiration date, away from sunlight.	15-25°C until expiration date, do not freeze.
Expected Values (Serum/plasma)	Comparable range for normal values	8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)	8.3 - 10.6 mg/dL (2.08 - 2.65 mmol/L)
Instrument	Compatible with clinical chemistry analyzers	T60 and DPC T60i, DPC T60i Kusti.	ADVIA® 2400 Chemistry system.
Measuring Range (Serum/plasma)	Comparable analytical measurement range	2.8 - 16.0 mg/dl (0.70 - 4.00 mmol/l)	1.0 - 15.0 mg/dL (0.25 - 3.75 mmol/L)
Precision (Within-run Serum)	Low SD and CV(%) values across levels	Level 4.0 mg/dL: SD=0.04, CV(%)=1.0; Level 8.4 mg/dL: SD=0.07, CV(%)=0.8; Level 11.9 mg/dL: SD=0.08, CV(%)=0.7	Level 6.2 mg/dL: SD=0.06, CV(%)=1.0; Level 8.5 mg/dL: SD=0.17, CV(%)=2.0; Level 10.9 mg/dL: SD=0.18, CV(%)=1.6
Precision (Total Serum)	Low SD and CV(%) values across levels	Level 4.0 mg/dL: SD=0.06, CV(%)=1.6; Level 8.4 mg/dL: SD=0.12, CV(%)=1.5; Level 11.9 mg/dL: SD=0.18, CV(%)=1.5	Level 6.2 mg/dL: SD=0.12, CV(%)=2.0; Level 8.5 mg/dL: SD=0.21, CV(%)=2.4; Level 10.9 mg/dL: SD=0.23, CV(%)=2.1
Method Comparison (Serum)	Strong correlation with predicate (R close to 1, slope close to 1, intercept close to 0)	y = 1.04x - 0.002, R = 0.994	y = 1.01x +0.27, R = 0.988 (vs ADVIA 1650); y = 1.00x - 0.56, R = 0.996 (vs reference method)
Limitations (Lipemia)	No significant interference up to a certain concentration	No interference found up to 1000 mg/dL (10 g/l) of Intralipid.	No significant interference found up to 625 mg/dl of Intralipid.
Limitations (Hemolysate)	No significant interference up to a certain concentration	No interference found up to 1000 mg/dl (10 g/l) of hemoglobin.	No significant interference found up to 525 mg/dl of hemoglobin.
Limitations (Bilirubin, conjugated)	No significant interference up to a certain concentration	No interference found up to 58 mg/dL (1000 µmol/l).	Not specified, but predicate states no significant interference up to 30 mg/dl for general Bilirubin.
Limitations (Bilirubin, unconjugated)	No significant interference up to a certain concentration	No interference found up to 58 mg/dL (1000 µmol/l).	Not specified, but predicate states no significant interference up to 30 mg/dl for general Bilirubin.

2. Sample Size Used for the Test Set and Data Provenance

Method Comparison (Serum):
- Sample Size: N = 112
- Data Provenance: Not explicitly stated, but it's a comparison to the Bayer ADVIA 2400. Given the submission is from Thermo Fisher Scientific Oy in Finland, and the clinical chemistry context, it's highly likely to be prospective clinical samples, but the country of origin is not specified. It is an in vitro diagnostic device, so the samples used for this study would be human serum/plasma.
Precision Studies:
- Sample Size: Not explicitly stated as "N" for the precision studies, but rather by "levels" (e.g., Level 4.0 mg/dL). Typically, precision studies involve running a sample multiple times within a run and across multiple runs. The 'SD' and 'CV(%)' values are calculated from these repeated measurements. The exact number of replicates is not provided.
- Data Provenance: Not explicitly stated. Likely laboratory-prepared control samples or spiked patient samples.
Limitations (Interference):
- Sample Size: Not explicitly stated. Interference studies typically involve spiking samples with known interferents at various concentrations.
- Data Provenance: Not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For this type of in vitro diagnostic device (a chemical assay), the "ground truth" is established through analytical reference methods or highly accurate laboratory instruments, not by human experts in the way image analysis or clinical diagnosis might be.

Method Comparison: The new device was compared to the predicate device (Bayer ADVIA 2400). The predicate device itself would have been validated against a reference method. The text also mentions the Bayer ADVIA Calcium assay's traceability to a NIST atomic absorption reference method.
Traceability: The new device's value has been assigned by using NIST SRM 909b as a primary reference. This implies that NIST standards and reference methods are the "ground truth" for calibrating and validating the assay.

Therefore, there were no human "experts" establishing ground truth in the sense of clinical reviewers for this device. The ground truth relies on established analytical standards and reference measurement procedures.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic assay, adjudication methods such as 2+1 or 3+1 (often used in clinical image interpretation) are not relevant. The "adjudication" is inherent in the analytical process, where results are compared against reference methods or statistically analyzed for agreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic tool or an imaging device requiring human interpretation. It is a chemical reagent and calibrator system for measuring calcium concentration. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, the entire performance evaluation presented is "standalone" for the device itself. The studies on precision, measuring range, and interference demonstrate the performance of the Calcium test system (reagents, calibrators, and the T60 instrument) independently. The method comparison study also assesses the direct output of the new device relative to the predicate without human intervention in result generation.

7. The Type of Ground Truth Used

The ground truth used for establishing the performance and enabling substantial equivalence determination includes:

NIST Standards: NIST SRM 909b for primary reference, and the predicate's traceability to a NIST atomic absorption reference method. (This is a form of highly certified reference measurement procedure/material).
Predicate Device Output: The Bayer ADVIA 2400 Chemistry System's Calcium assay served as the comparative "ground truth" for the method comparison study. The predicate itself would have been validated against a reference standard.
Laboratory Control Materials/Spiked Samples: Likely used for precision and interference studies.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a "training set" in the computational sense. It is a chemical reagent-based assay. Its performance is characterized through traditional analytical validation, not by training an algorithm on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this chemical assay device.

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K Number

K073191

Device Name

ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL

Manufacturer

THERMO FISHER SCIENTIFIC OY

Date Cleared

2008-02-28

(107 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K991576

Intended Use

For in vitro diagnostic use in the quantitative determination of alkaline phosphatase (orthophosphoric - monoester phospho-hydrolase, alkaline optimum, EC 3.1.3.1) activity in human serum or plasma on T60 instruments according to the IFCC method.

The Alkaline Phosphatase test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme Alkaline Phosphatase in serum and plasma on T60 instrument according to the IFCC method. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver and bone diseases.

For in vitro diagnostic use on T60 instrument. eCal is used as a calibrator for enzyme tests using methods defined by Thermo Fisher Scientific Oy.

Device Description

Alkaline Phosphatase (IFCC) plus, codes 981832 and 981833. Common name: Alkaline Phosphatase (IFCC). Classification: Clinical Chemistry, Class II, Product Code: CJE.
eCal, code 981830. Common Name: Calibrator, Multi-Analyte Mixture. Classification: Clinical Chemistry, Class II, Product Code: JIX.
Nortrol, code 981043. Common Name: Multi-analyte Controls (Assayed and unassayed). Classification: Clinical Chemistry, Class I, Product Code: JJY.
Abtrol, code 981044. Common Name: Multi-analyte Controls (Assayed and unassayed). Classification: Clinical Chemistry, Class I, Product Code: JJY.

AI/ML Overview

The acceptance criteria and device performance for the Alkaline Phosphatase (IFCC) Plus test system are detailed below based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (New Device #1)
Measuring Range	0-1100 U/L	20 - 1000 U/L
Precision (Within run)
Level 68 U/l	SD= 0.9, CV(%)= 1.3	Level 91 U/l: SD= 0.7, CV(%)= 0.7
		Level 127 U/l: SD=0.9, CV(%)=0.7
		Level 374 U/l: SD= 2.0, CV(%)=0.5
		Level 41 U/l: SD= 0.5, CV(%)= 1.1
		Level 810 U/l: SD= 6.6, CV(%)=0.8
Precision (Within run)
Level 148 U/l	SD=2.1, CV(%)= 1.4	Level 91 U/l: SD= 0.8, CV(%)=0.9
		Level 127 U/l: SD= 1.1, CV(%)=0.9
		Level 374 U/l: SD= 2.0, CV(%)=0.5
		Level 41 U/l: SD= 1.4, CV(%)= 3.5
		Level 810 U/l: SD= 2.5, CV(%)=0.3
Precision (Total)
Level 68 U/l	SD= 2.2, CV(%)= 3.2	Level 91 U/l: SD= 2.9, CV(%)= 3.2
		Level 127 U/l: SD= 2.6, CV(%)= 2.0
		Level 374 U/l: SD= 8.4, CV(%)=2.3
		Level 41 U/l: SD= 1.5, CV(%)= 3.7
		Level 810 U/l: SD= 18.5, CV(%)= 2.3
Precision (Total)
Level 148 U/l	SD= 3.8, CV(%)= 2.6	(Not directly comparable levels)
Method Comparison	y = 1.00x + 1.1, r = 0.998, n = 402 (with Advia 1650)	y = 1.023x - 1.61, R = 0.998, N = 154
	y = 1.04x - 14.6, r = 0.998, n = 96 (with reference method)	(Comparison with predicate device)
Limitations (Lipemia)	No significant interference found up to 500 mg/dl	No interference found up to 1000 mg/dL
Limitations (Hemolysate)	No significant interference found up to 500 mg/dl	No interference found up to 300 mg/dl
Limitations (Bilirubin)	No significant interference found up to 25 mg/dl (unspecified type)	Conjugated: No interference up to 58 mg/dL; Unconjugated: No interference up to 21 mg/dL

Note: The table above primarily compares the new device's performance against the predicate device's stated performance, which is implicitly treated as the acceptance criteria for determining substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

Method Comparison (New device vs. Predicate device):
- Sample size (N): 154
- Data Provenance: Not explicitly stated, but given that the submitter is Thermo Fisher Scientific Oy (Finland), it is likely that parts of the study were conducted in Finland or other relevant locations. The data type is prospective, as it involves testing the device against clinical samples.
Limitations (Interference):
- The sample size for interference studies (Lipemia, Hemolysate, Bilirubin) is not specified.
- Data Provenance: Not explicitly stated, but assumed to be from internal studies conducted by Thermo Fisher Scientific Oy. This would be prospective data generated under controlled conditions.

3. Number of Experts and Qualifications for Ground Truth

This document describes an In Vitro Diagnostic (IVD) assay for measuring alkaline phosphatase activity. For such assays, "ground truth" is typically established by:

Reference Methods: The document states the new device is "traceable to the molar absorbance coefficient of p-nitrophenol" and the predicate device is "traceable to the IFCC reference method via patient sample correlation."
Consensus or Clinical Outcomes: For IVD tests, the "ground truth" for patient samples is usually the result obtained from a well-established, often older or gold-standard, clinical laboratory method or a reference laboratory test.
For this specific document: The "ground truth" for the method comparison study (N=154) was the measurements produced by the identified predicate device (Bayer ADVIA 2400 Chemistry System) or the reference method mentioned for the predicate. The document does not mention the involvement of "experts" in the sense of clinicians or radiologists establishing ground truth by medical review or interpretation. The ground truth here is the quantitative measurement provided by the comparative method.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative diagnostic assay, not an image-based diagnostic or clinical decision-support system requiring adjudication of interpretations by clinical experts. The comparison is based on numerical results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an IVD device measuring an enzymatic activity directly, not an AI system assisting human readers in interpreting clinical cases. Therefore, there is no "human readers improve with AI vs without AI assistance" effect to measure.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)

Yes, this study is inherently a standalone performance study. The Alkaline Phosphatase (IFCC) Plus test system, as an IVD, operates autonomously to measure the analyte concentration. Its performance (precision, measuring range, method comparison, limitations) is evaluated based on its own output, independent of human interaction or interpretation beyond running the assay and interpreting the numerical result.

7. Type of Ground Truth Used

The ground truth used for the method comparison study was quantitative measurements obtained from the predicate device (Bayer ADVIA 2400 Chemistry System) or a referenced IFCC method. This is a form of comparative measurement data or reference method equivalency. The internal validation "ground truth" for linearity, precision, and interference would be based on known concentrations or controlled interference levels.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. For an IVD assay like this, method development and optimization (which could be analogous to "training") typically involve numerous experiments with various reagents, concentrations, and conditions. However, the document focuses on the validation or test set used for substantial equivalence demonstration.

9. How the Ground Truth for the Training Set was Established

As no specific "training set" is mentioned in the context of machine learning, this question is not directly applicable. For the development of the assay, the "ground truth" during optimization would be established through standard analytical chemistry techniques, using known concentrations of alkaline phosphatase, reference materials, and established biochemical principles (e.g., spectrophotometry for p-nitrophenol formation) to ensure the assay accurately measures the intended activity.

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K Number

K070824

Device Name

CREATININE (ENZYMATIC)

Manufacturer

THERMO FISHER SCIENTIFIC OY

Date Cleared

2007-12-03

(252 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K024098

Intended Use

The CREATININE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine using T60 Clinical Chemistry Analyzers. Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

sCal: For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

Nortrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.

Abtrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.

Device Description

Not Found

AI/ML Overview

This document describes the regulatory submission for a diagnostic device, not an AI/ML powered device. As such, concepts like "AI vs without AI assistance," "standalone performance," or "training set" are not applicable. The information provided focuses on the analytical performance of the Creatinine (Enzymatic) assay and its substantial equivalence to a predicate device.

Here's an analysis of the provided text based on the request, reinterpreting some terms for a diagnostic assay where appropriate:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are not explicitly stated in a quantifiable manner (e.g., "CV must be

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K Number

K071340

Device Name

CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL

Manufacturer

THERMO FISHER SCIENTIFIC OY

Date Cleared

2007-10-05

(144 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K032377

Intended Use

Carbon Dioxide (CO2) reagent is intended for the quantitative determination of total carbon dioxide in human serum and plasma (Li-heparin) on T60 analyzer.

Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, portassium and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes

sCal: For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Over

Device Description

Not Found

AI/ML Overview

The provided text describes the 510(k) summary for a Carbon Dioxide (CO2) measurement device, along with associated calibrators and controls. The study focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a novel device or AI algorithm. Therefore, many of the requested details about acceptance criteria, ground truth, and AI-specific study designs are not applicable or extractable from this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the new device must meet to demonstrate clinical effectiveness. Instead, it aims to demonstrate substantial equivalence to an existing predicate device (Roche Diagnostics Corporation, model Hitachi 911 Roche Diagnostics Corporation item: CO2-L (Bicarbonate Liquid) (K032377)). The performance characteristics of the new device are presented in comparison to this predicate.

Implicit Acceptance Criteria (for Substantial Equivalence): The implicit acceptance criteria are that the new device's performance characteristics (intended use, indications for use, assay protocol, traceability, sample type, reagent storage, expected values, instrument compatibility, measuring range, precision, method comparison, and limitations) are sufficiently similar or equivalent to those of the predicate device, and that any differences do not raise new questions of safety or effectiveness.

Attribute	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (New Device #1 - Carbon Dioxide (CO2))
Intended Use	For in vitro diagnostic use in the quantitative determination of bicarbonate in human serum and plasma on Roche automated clinical chemistry analyzers.	For in vitro diagnostic use in the quantitative determination of the bicarbonate (CO2) concentration in human serum or plasma (Li-heparin) on T60 instrument.
Indication for Use	Bicarbonate measurements used in assessment of acid-base balance.	Carbon Dioxide (CO2) Reagent is intended for the quantitative determination of total carbon dioxide in human serum. Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, potassium and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes.
Assay Protocol	Enzymatic rate	Enzymatic rate
Traceability/Standardization	Traceable to NIST	Traceable to RCPA AQAP Cycle 71
Sample Type	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin)
Reagent Storage	Shelf life at 2 to 8 °C until the expiration date on cassette.	Reagents in unopened vials are stable at 2...8 °C until the expiry date printed on the label.
Expected Values	Adult: 22 - 29 mmol/L	Adult: 22 - 29 mmol/L
Instrument	Hitachi 911	T60 and DPC T60i, DPC T60i Kusti
Measuring Range	1.5 - 50 mmol/L	5 - 40 mmol/L
Precision (Within run)	Level 20.5 mmol/L: SD = 0.18, CV(%) = 0.9
Level 34.4 mmol/L: SD = 0.19, CV(%) = 0.6	Level 15.7 mmol/L: SD = 0.3, CV(%) = 1.9
Level 25.2 mmol/L: SD = 0.4, CV(%) = 1.6
Level 34.3 mmol/L: SD = 0.4, CV(%) = 1.3
Precision (Between run)	Level 17.8 mmol/L: SD = 0.4, CV(%) = 2.5
Level 29.8 mmol/L: SD = 0.5, CV(%) = 1.8	Level 15.7 mmol/L: SD = 0.8, CV(%) = 5.3
Level 25.2 mmol/L: SD = 1.0, CV(%) = 3.9
Level 34.3 mmol/L: SD = 1.5, CV(%) = 4.5
Precision (Total)	Not explicitly stated for predicate; implied by within/between run values.	Level 15.7 mmol/L: SD = 1.0, CV(%) = 6.1
Level 25.2 mmol/L: SD = 1.2, CV(%) = 4.9
Level 34.3 mmol/L: SD = 1.6, CV(%) = 4.7
Method Comparison (Regression Analysis)	Y = 1.01 x - 0.89, R = 0.998, Range 0.67 to 46 mmol/L, N = 59	Serum and plasma (Li-heparin): y = 0.978x + 1.23, R = 0.983, Range 9.1 to 49.5 mmol/L, N = 100
Serum: y = 0.972x + 1.40, R = 0.9835, Range 9.1 to 49.5 mmol/L, N = 71
Plasma (Li-heparin): y = 1.046x - 0.24, R = 0.9816, Range 11.4 to 45.2 mmol/L, N = 29
Limitations (Interference - Lipemia)	No significant interference up to an L index of 2000.	No interference found up to 2000 mg/dL (20 g/l) of Intralipid.
Limitations (Interference - Hemoglobin)	No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L).	No interference found up to 1000 mg/dL (10 g/l) of hemoglobin.
No interference found up to 400 mg/dL (4 g/l) of hemoglobin in hemolysate.
Limitations (Interference - Bilirubin)	No significant interference up to an I index of 60 for conjugated bilirubin and an I index of 50 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L; approximate unconjugated bilirubin concentration: 50 mg/dL or 855 µmol/L).	Bilirubin, conjugated: No interference found up to 60 mg/dL (1000 µmol/l) of conjugated bilirubin.
Bilirubin, unconjugated: No interference found up to 60 mg/dL (1000 µmol/l) of unconjugated bilirubin.

Study Details:

Sample sizes used for the test set and the data provenance:
- Method Comparison Test Set:
  - Total samples: 100 (Serum and plasma (Li-heparin))
  - Sub-sets:
    - Serum: 71 samples
    - Plasma (Li-heparin): 29 samples
  - Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This information is typically not included in a 510(k) summary for in-vitro diagnostic devices unless specific clinical trials were performed in particular regions. It's likely from an in-house evaluation setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this type of IVD device. The "ground truth" for chemical analyzers is established through reference methods or highly calibrated instruments, not by expert interpretation. The performance is assessed by comparing results to a predicate device or by established analytical methods for precision and linearity.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis), not for objective chemical measurements where results are quantitative values.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool or an imaging device requiring human interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone diagnostic measurement device. Its performance, as described in precision and method comparison, represents its "standalone" analytical capability. It does not involve an "algorithm" in the AI sense, but rather a chemical reaction and measurement process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference for the method comparison was the predicate device (Roche Diagnostics Corporation CO2-L (Bicarbonate Liquid) on a Hitachi 911). Precision was evaluated using control materials. Traceability for the new device is to "RCPA AQAP Cycle 71" and for the predicate to "NIST," indicating standardized external reference materials or accreditation schemes.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. Its development involves chemical and engineering principles validated through analytical studies.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an AI-driven device.

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K Number

K071580

Device Name

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

Manufacturer

THERMO FISHER SCIENTIFIC OY

Date Cleared

2007-10-03

(117 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K992136

Intended Use

The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.

Auxiliary product: Pyridoxal Phosphate
Auxiliary reagent for in vitro diagnostic use in the quantitative determination of ALT (GPT) and AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument.

For eCal Calibrator, Nortrol and Abtrol see intended use.

Device Description

Not Found

AI/ML Overview

The provided submission describes an in vitro diagnostic device (IVD) for the quantitative determination of aspartate aminotransferase (AST/GOT) activity. It is not an AI/ML powered device, so many of the requested categories (e.g., number of experts, adjudication method, MRMC study, training set) are not applicable.

Here's the breakdown of the acceptance criteria and study information provided for the AST/GOT (IFCC) device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the performance characteristics of the new device to those of the predicate device (Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay (K992136)). The goal is to demonstrate "substantial equivalence."

Attribute / Acceptance Criteria (Implied by Predicate)	New Device (AST/GOT (IFCC)) Performance	Predicate Device (Bayer ADVIA IMS AST assay) Performance
Intended Use	For in vitro diagnostic use in the quantitative determination of aspartate aminotransferase (L-Aspartate: 2-Oxoglutarate Aminotransferase (AST), EC 2.6.1.1) activity in human serum or plasma on T60 instrument.	For in vitro diagnostic use in the quantitative determination of aspartate aminotransferase activity in human serum and plasma on the ADVIA Chemistry systems. Such measurements are used mainly to determine the progress and prognosis of patients with myocardial infarction and the diagnosis and monitoring of liver disease.
Indication for Use	The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.	See intended use.
Assay Protocol	1-reagent method: Modified IFCC reference method (without PyP)
3-reagent method: IFCC reference method	1-reagent method: Modified IFCC
3-reagent method: IFCC
Traceability/Standardization	The AST/ GOT (IFCC) 1-reagent method is traceable to the molar absorbance coefficient of NADH.
The AST/ GOT (IFCC) 3-reagent method is traceable to the IFCC reference method.	The ADVIA AST and AST P5P method standardization is traceable to the IFCC reference method via patient sample correlation.
Sample Type	Serum, plasma (heparin)	Serum, plasma (Li-heparin)
Reagent Storage	Reagents in unopened vials are stable at 2...8 °C until the expiration date printed on the label when protected from light.	Unopened reagents are stable until the expiration date printed on the product label when stored at 2 - 8°C.
Expected Values	Male:

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