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Reference & Predicate Devices

k132664

Intended Use

The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The assay is intended for professional use only.

For In Vitro Diagnostic use only.

Device Description

Albumin BCP reagent is ready to use liquid reagent that is supplied in two configurations: fill volume 20 mL in a 20 mL wedge or 50 mL in a 50 mL wedge, 6 wedges/kit.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the Albumin BCP device, based on the provided text:

Acceptance Criteria and Device Performance

Study	Acceptance Criteria (Required Performance)	Reported Device Performance (Achieved)
Limit of Blank (LoB)	≤ 1 g/L	0.3 g/L (highest observed)
Limit of Detection (LoD)	≤ 3 g/L	0.8 g/L (highest observed)
Limit of Quantitation (LoQ)	≤ 5 g/L	1.5 g/L (claimed)
Precision	≤ 2.5% CV (across all tested concentrations)	Highest %CV: 2.2%
Intra Assay Precision	≤ 1.5% CV (across all tested concentrations)	All samples gave %CV lower than 1.5% (e.g., 0.40% to 0.95%)
Linearity (Measuring Range)	Absolute bias: - 2 g/L to + 2 g/L OR Relative bias: -6% to + 6%	Linear up to 70 g/L (e.g., y = 0.00 + 1.000x, r = 0.999)
Endogenous Interferences	% bias: ±10% for Hemoglobin (2000 mg/dL), Unconjugated bilirubin (66 mg/dL), Conjugated bilirubin (66 mg/dL), Lipids (as Triglycerides) (2000 mg/dL)	Met acceptance criteria for all tested substances at specified concentrations (Lipids up to 1200 mg/dL)
Reagent Stability	% Bias: within ± 10% vs initial measurement	Min %bias: -1.3%, Max %bias: 10.0%
Method Comparison	Regression slope of 1.00 (± 0.10) and a correlation coefficient (r) of ≥ 0.975	Passing & Bablok: y = 0.94x + 1.01, r = 0.992; Linear fit: y = 0.95x + 0.78, r = 0.992
Matrix Comparison (Serum vs. Lithium-Heparin plasma)	Regression slope of 1.00 (± 0.10) and a correlation coefficient (r) of ≥ 0.975	Passing & Bablok: y = 1.01x - 0.34, r = 0.995; Linear fit: y = 1.00x + 0.01, r = 0.995
Matrix Comparison (Serum vs. Potassium EDTA plasma)	Regression slope of 1.00 (± 0.10) and a correlation coefficient (r) of ≥ 0.975	Passing & Bablok: y = 1.00x - 0.20, r = 0.996; Linear fit: y = 0.995x - 0.05, r = 0.996

Note regarding "Test Set" and "Training Set" terminology: For in vitro diagnostic assays measuring specific analytes, the concepts of "test set" and "training set" (as typically used in machine learning or image analysis) are not directly applicable in the same way. Instead, performance studies use different sample types (e.g., control materials, patient samples, spiked samples) to validate the analytical performance characteristics. The following answers reflect this distinction.

Study Details:

Sample sizes used for the test set and the data provenance:
- Limit of Blank (LoB): Not explicitly stated, but performed with three different reagent lots (F0390, F0391, F0480) and one calibrator lot (E0179). LoB is typically determined using replicate measurements of blank samples.
- Limit of Detection (LoD): Not explicitly stated, but inferred to be similar to LoB determination as it also uses reagent and calibrator lots.
- Limit of Quantitation (LoQ): Not explicitly stated, inferred to be similar to LoB/LoD determination.
- Precision Study: 80 replicates per level for three different reagent lots (F0390, F0391, F0480) across three levels (26.26-26.62 g/L, 40.53-40.67 g/L, 49.96-50.47 g/L) using human serum. An additional lot (90228) used 88 replicates per level (19.10 g/L, 40.18 g/L, 51.33 g/L).
- Intra Assay Precision Study: 20 replicates per level for three different reagent lots (F0390, F0391, F0480) across three levels (21.4-21.5 g/L, 35.6-35.8 g/L, 50.2-50.3 g/L) using human serum.
- Linearity (Measuring Range): Three different reagent lots (F0390, F0391, F0480) were tested across specified ranges (e.g., 4.17 to 78.30 g/L). Number of distinct samples within these ranges not explicitly stated.
- Endogenous Interferences Study: "2 aliquots of serum pool were prepared (Base and Test pool)" for two albumin concentrations (~35 g/L and ~50 g/L), with the test pool divided into 4 sub-aliquots and diluted. Specific number of interference samples not stated, but covered a range of dilution levels (100% down to 0%).
- Reagent Stability: Four different lots (F0390, F0391, F0480, 90228) were evaluated across three different concentration levels.
- Method Comparison: 128 serum samples, including 8 altered samples, covering the measuring interval 6.0 - 70 g/L.
- Matrix Comparison: 77 paired plasma/serum samples, including 7 altered samples, covering the assay's range, for both Lithium-Heparin plasma and Potassium EDTA plasma.
Data Provenance: The studies used human serum and plasma samples. The document does not explicitly state the country of origin of the data or whether the samples were collected retrospectively or prospectively. Given the context of a medical device submission, these would typically be from clinical laboratory settings.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This is an in vitro diagnostic (IVD) assay for measuring a biochemical analyte (albumin). The "ground truth" for such assays is established by the reference methods or highly characterized materials used to calibrate and validate the assay. It does not involve human experts interpreting images or diagnosing conditions, but rather relies on established analytical standards and predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., image reading) where disagreement among experts might arise. For quantitative IVD assays, performance is assessed against defined analytical criteria and reference 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 is an in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the performance studies described are for the standalone functioning of the Albumin BCP assay on the AU680 Automatic Analyzer. This is inherent to the nature of an in vitro diagnostic test, where the device performs the measurement independently.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):

The "ground truth" for this IVD device is established through:
- Reference materials and calibrators: Used to ensure accuracy and traceability of measurements (e.g., ERM-DA 470k/IFCC for standardization).
- Predicate device measurements: The method comparison study used a legally marketed predicate device (Siemens ADVIA 2400, ADVIA® Chemistry Albumin BCP assay) as a comparative standard.
- Analytical standards: Performance is measured against accepted analytical performance guidelines (e.g., CLSI documents EP17-A2, EP05-A3, EP15-A3, EP6-A, EP07-A2, EP09-A3) which define acceptable limits for various performance characteristics.
- Known concentrations: For studies like LoB, LoD, LoQ, Precision, and Intra-Assay Precision, samples with known or characterized concentrations (e.g., control materials, spiked samples, serum pools) are used to assess the device's accuracy and reproducibility.
The sample size for the training set:

Not applicable in the machine learning sense. The device is a chemical assay, not an algorithm trained on a dataset. Its analytical characteristics are inherently designed and validated through laboratory studies.
How the ground truth for the training set was established:

Not applicable. As explained above, this device does not utilize a "training set" in the context of machine learning. The analytical methods and performance targets are established through scientific principles of chemistry and validated using established laboratory practices and reference standards.

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K Number

K192118

Device Name

CRP Vario

Manufacturer

Sentinel CH, Spa

Date Cleared

2019-11-08

(94 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

k051564,k112412,k050836

Intended Use

The CRP Vario assay [CRPVa] is for in vitro diagnostic use in the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma (sodium and lithium heparin) using the ARCHITECT c Systems. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.

CRP Calibrators (including CRP Calibrator Set, CRP Calibrator HS and CRP Calibrator WR) are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum or plasma samples.

Device Description

The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma. It is supplied as a two-reagent kit. The kit contains Reagent 1 (Glycine buffer) and Reagent 2 (Anti-CRP polyclonal antibodies adsorbed on latex particles). Two different sizes of the product are available. The submission also describes CRP Calibrators (CRP Calibrator Set, CRP Calibrator HS, and CRP Calibrator WR) which are prepared by diluting CRP with human serum and stabilized by adding sodium azide.

AI/ML Overview

Here's an analysis of the acceptance criteria and study as described in the provided document:

Acceptance Criteria and Device Performance for CRP Vario

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly refers to an "Acceptance Criteria" column for Method Comparison in Table 15-3. For other performance characteristics, the "acceptance criteria" can be inferred by comparing the candidate device's stated performance to that of the predicate device, or by general statements about meeting recommendations or consistency with original submissions.

Feature	Acceptance Criteria	Reported Device Performance (Candidate Device CRP Vario)	Met?
Method Comparison
High Sensitivity Method (Slope)	0.95 – 1.05	0.969 (0.964 – 0.974)	Yes
High Sensitivity Method (R)	≥ 0.975	1.000	Yes
High Sensitivity Method (n)	≥ 100	111	Yes
Standard Method (Slope)	0.95 – 1.05	0.956 (0.925 – 0.997)	Yes
Standard Method (R)	≥ 0.975	1.000	Yes
Standard Method (n)	≥ 100	119	Yes
Wide Range Method (Slope)	0.95 – 1.05	0.976 (0.944 – 0.993)	Yes
Wide Range Method (R)	≥ 0.975	1.000	Yes
Wide Range Method (n)	≥ 100	119	Yes
Limit of Quantitation (LoQ)
LOQ for hsCRP	≤ 0.03 mg/dL	"The LOQ results are consistent with the original submission." (Original submission stated 0.01 mg/dL for High Sensitivity Method, which is the hsCRP method).	Yes
LOQ for Standard and Wide Range Methods	≤ 0.05 mg/dL	"The LOQ results are consistent with the original submission." (Original submission stated 0.02 mg/dL for Standard and Wide Range Methods).	Yes
Linearity
High Sensitivity Method	Meets pre-specified allowable error criteria against 2nd and 3rd order polynomial fits.	Found to extend up to 16.00 mg/dL.	Yes
Standard Method	Meets pre-specified allowable error criteria against 2nd and 3rd order polynomial fits.	Found to extend up to 32.00 mg/dL.	Yes
Wide Range Method	Meets pre-specified allowable error criteria against 2nd and 3rd order polynomial fits.	Found to extend up to 48.00 mg/dL.	Yes

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

Method Comparison Test Set:
- High Sensitivity Method: N = 111 human serum samples
- Standard Method: N = 119 human serum samples
- Wide Range Method: N = 119 human serum samples
- Data Provenance: The document states "Human serum samples, spanning the measuring range, were tested." No information is provided regarding the country of origin or whether the data was retrospective or prospective.
Limit of Quantitation (LoQ) Test Set:
- The study used serum pools diluted with SeraSub (a synthetic serum) to create 8 low-level analyte samples (0.08, 0.06, 0.05, 0.04, 0.03, 0.02, 0.01, and 0.005 mg/dL).
- Each sample was tested in a minimum of 10 replicates per run, with 2 runs per day over 3 days, resulting in a total of 60 replicates per sample.
Linearity Test Set:
- A high CRP serum pool was mixed with a low serum pool to generate 12 concentrations.
- Each concentration level was tested in triplicate determinations.

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

This section is not applicable to this type of device and study. The CRP Vario is an in vitro diagnostic device that quantifies C-reactive protein. Its performance is evaluated against reference methods (e.g., predicate devices, established analytical protocols) and CLSI guidelines, not against expert human interpretations of images or clinical reports. There are no "experts" establishing a subjective ground truth in the way described for AI in image analysis.

4. Adjudication Method for the Test Set

This section is not applicable. As an in vitro diagnostic device, the performance is determined by quantitative measurements and statistical comparisons with reference methods, not by adjudication of interpretations by multiple human readers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study evaluates human reader performance often in the context of imaging diagnostics. The CRP Vario is an in vitro diagnostic for laboratory analysis, not a device requiring human interpretation in this manner.

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

Yes, the studies reported here (Method Comparison, Linearity, Limit of Quantitation) are standalone performance evaluations of the CRP Vario assay. The device itself is an automated immunoturbidimetric system (ARCHITECT c8000 system) for quantitative measurement, operating without human interpretation of the final result, beyond standard laboratory quality control and result reporting.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the CRP Vario was established by:

Reference Methods / Predicate Device: For the Method Comparison study, the candidate CRP Vario (traceable to ERM-DA472/IFCC) was compared against a Beckman Coulter CRP Latex REF. OSR6199 (traceable to CRM 470) on an AU5800 platform.
CLSI Guidelines: Formal CLSI (Clinical and Laboratory Standards Institute) protocols (EP09-A3 for Method Comparison, EP06-A for Linearity, EP17-A2 for LoQ) were followed, indicating that the acceptable statistical and analytical measures defined by these standards served as the basis for evaluating performance.
Dilution Series / Known Concentrations: For Linearity and LoQ, the "ground truth" was derived from precisely prepared serum pools and their serial dilutions to known or targeted concentrations.

8. The Sample Size for the Training Set

This section is not applicable. The CRP Vario is a re-submission for a modification of an existing in vitro diagnostic device, not an AI/ML device that requires a distinct "training set" in the computational sense. Its performance is characterized through analytical verification and validation studies.

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

This section is not applicable for the reasons stated in point 8.

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K Number

K173833

Device Name

CRP Vario

Manufacturer

Date Cleared

2018-09-27

(283 days)

Product Code

NQD

Regulation Number

866.5270

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum or plasma. Cardiac CRP High Sensitive (cCRP) may be used for aid in identification of individuals at risk for cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, the cCRP may be useful as an independent marker of prognosis for recurrents, in patients with stable coronary disease or acute coronary syndrome.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) Premarket Notification clearance letter for a device called "CRP Vario." This document primarily
confirms the FDA's determination of substantial equivalence for a medical device to
a legally marketed predicate device.

Crucially, this document focuses on regulatory clearance and does NOT contain the detailed study information required to answer the
questions about acceptance criteria and device performance.

Specifically, the document states:

"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
The "Indications for Use" section describes what the device is intended for (quantitative immunoturbidimetric determination of C-reactive protein in human serum or plasma, and its use as an aid in identification of individuals at risk for cardiovascular disease).

To answer your questions about the acceptance criteria and the study that proves the device meets them, one would typically
need access to the underlying 510(k) submission document itself or efficacy study reports, which are not part of this
publicly available clearance letter.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets, data provenance, training set size, or how ground truth was established.
Details about expert involvement (number, qualifications, adjudication methods).
Information on MRMC comparative effectiveness studies or standalone algorithm performance.
The type of ground truth used.

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K Number

K141728

Device Name

ACE CALIBRATOR

Manufacturer

Date Cleared

2014-07-28

(32 days)

Product Code

JIT

Regulation Number

862.1150

Type

Abbreviated

Panel

Reference & Predicate Devices

k930477

Intended Use

The ACE Calibrator is a device intended to be used with the Sentinel ACE Liquid Reagent for the preparation of the calibration curve for the kinetic determination of angiotensing enzyme (ACE) assay in human serum or plasma. The product is for in vitro diagnostic use only.

Device Description

The ACE Calibrator is a single level, single analyte serum based calibrator. It consists of a lyophilized preparation of human serum containing angiotensin converting enzyme (porcine source), in a buffered human serum base with added preservatives and stabilizers. The kit consists of six vials, containing 1 mL per vial. Once reconstituted, the calibrator is stable for 7 days when stored capped at 2-8°C.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria	Sentinel ACE Calibrator Performance
Value Assignment & Verification Process	Defined acceptance criteria met.	"Defined acceptance criteria was met for the value assignment and verification process."
Shelf-life Stability (Lyophilized)	Stability for at least 36 months (3 years) at 2-8°C.	Stable for at least 38 months when stored sealed at 2-8°C.
Reconstituted Stability (Open Vial)	Within ± 5.0% difference in ACE recoveries between fresh calibrator and calibrator reconstituted and stored for 7 days at 2-8°C.	"The results demonstrated that the ACE Calibrator met the acceptance criteria of within ± 5.0% difference in ACE recoveries between fresh calibrator and calibrator reconstituted and stored for 7 days at 2-8°C."

2. Sample Size and Data Provenance for Test Set

Sample Size for Value Assignment: For the primary value assignment, five replicates of pooled ACE calibrator were analyzed on each run across two Abbott Architect analyzers over two days, resulting in a total of 20 replicates.
Sample Size for Shelf-life Stability: Two distinct batches of ACE Calibrator were used.
- Batch #1: Data collected over 46 months.
- Batch #2: Data collected over 38 months.
Sample Size for Reconstituted Stability: Three vials of ACE Calibrator were reconstituted and pooled. Testing occurred at Day 0 (fresh), Day 2, Day 7, and Day 8. The calibrator and controls were run in triplicate for each test point.
Data Provenance: The document does not explicitly state the country of origin for the data; however, the submitter is from Milano, Italy. The value assignment utilized proficiency survey material from the College of American Pathologists (CAP) ACE program and WEQAS (Wales External Quality Assurance Scheme), suggesting international reference materials were incorporated. All studies mentioned are prospective in nature, as they involve testing the device under controlled conditions to determine its performance and stability.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention a specific number of experts or their qualifications for establishing ground truth for the test set.
For the value assignment (a form of ground truth establishment for the calibrator's value), it mentions using proficiency survey material from CAP ACE program and WEQAS. While these programs rely on expert consensus or established methodologies, the document doesn't detail the number or qualifications of experts involved in those programs.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (like 2+1 or 3+1) for the test set. The performance testing relies on quantitative measurements and comparisons against predefined criteria rather than subjective expert review.

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

No, an MRMC comparative effectiveness study was not done. This device is a calibrator, not an imaging or diagnostic device that typically involves human reader interpretation. Therefore, a study comparing human readers with and without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study

Yes, the studies reported are essentially standalone performance studies for the calibrator. The device is a calibrator, and its performance is assessed intrinsically (e.g., its ability to maintain its assigned value over time, its stability when reconstituted) on analytical instruments (e.g., Abbott Architect analyzers, Cobas Mira) against established reference materials or its initial performance. There is no "human-in-the-loop" aspect to its performance as a calibrator.

7. Type of Ground Truth Used

For Value Assignment: The ground truth for the calibrator's assigned value was established by targeting traceability to the Trinity Biotech ACE reagent system a market leader, and using proficiency survey material from CAP ACE program and WEQAS. This leans towards a form of expert consensus/reference method through established external quality assurance programs and a highly regarded commercial product.
For Stability Studies: The ground truth for stability was the initial performance/recovery value of the calibrator at the time of manufacture. Subsequent measurements were compared against this baseline.

8. Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. This device is a calibrator, and its development and validation do not involve AI model training.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no mention of a training set for an AI model.

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K Number

K102706

Device Name

CKMB UDR ASSAY

Manufacturer

Date Cleared

2011-08-19

(333 days)

Product Code

JHS

Regulation Number

862.1215

Type

Panel

Reference & Predicate Devices

K003158

Intended Use

The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC 600 System of the CK-MB isoenzyme activity of creatine kinase in serum and Liheparin plasma by inhibition method. The assay is intended for professional use only. Creatine Kinase (CK) catalyses the reversible phosphorylation of creatine by ATP. CK is a dimer composed of two subunits which form three active isoenzymes: BB (CK-1), MB (CK-2), MM (CK-3). CK-BB isoenzyme only rarely appears in serum.

Elevated CK values are due to muscular damages and associated pathologies. CK determination, usually performed with CK2 (also called CK-MB), is used for the diagnosis and follow-up of AMI (acute myocardial infarction) and some muscular diseases.

Device Description

Anti CK-M mouse monoclonal antibodies in the reagent 1 inhibit the CK-M subunit in the sample without affecting the CK-B subunits. The CK-B activity is determined by the CK-NAC method and corresponds to half the CK-MB activity.

AI/ML Overview

The provided text describes the performance characteristics of the CKMB UDR Assay, focusing on its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison with Predicate Device:
High correlation coefficient (r) with predicate device	r = 0.999
Slope close to 1 with predicate device	Slope = 0.96
Small intercept value with predicate device	Intercept = 2.40 U/L
Imprecision (within-run and inter-assay):
Acceptable %CV values for various concentrations	20-day Inter-assay Imprecision:
	- Human sera pool #1 (Mean 10.7 U/L): Total Imprecision CV% = 4.2%, Within run CV% = 4.2%
	- Human sera pool #2 (Mean 19.0 U/L): Total Imprecision CV% = 2.6%, Within run CV% = 2.6%
	- Human sera pool #3 (Mean 25.4 U/L): Total Imprecision CV% = 2.0%, Within run CV% = 2.0%
	- Human sera pool #4 (Mean 33.4 U/L): Total Imprecision CV% = 3.6%, Within run CV% = 3.6%
	- Spiked Human sera pool (Mean 584.1 U/L): Total Imprecision CV% = 0.9%, Within run CV% = 0.6%
Analytical Measurement Range (AMR):
A defined and clinically relevant range of accurate measurement.	Found lower limit: 7.4 U/L; Found upper limit: 600.0 U/L. Claimed AMR: 9.0 to 600.0 U/L.

Study Proving Acceptance Criteria (Type of Study):

The study described is a comparative performance study to demonstrate substantial equivalence to a predicate device (Roche CK-MB assay K003158). This is primarily an analytical validation study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: 306 human sera samples (for method comparison).
Data Provenance: The text does not specify the country of origin. It implicitly describes a prospective study in the sense that samples were tested with both the new device and the predicate for comparison. However, the exact collection method (e.g., whether samples were collected specifically for this study or were existing banked samples) is not explicitly stated. It is referred to as "human sera samples," suggesting clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of analytical device validation. The "ground truth" for an assay like CKMB is established by the reference method (in this case, the predicate device) and the intrinsic chemical/biological properties being measured, not by expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or adjudication of results. The comparison is quantitative between two analytical instruments.

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 an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies described are standalone (algorithm/assay only) performance assessments. The device measures CK-MB activity directly, and its performance is evaluated based on its analytical characteristics (correlation, precision, range) against a predicate device, without human intervention in the result determination.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the results obtained from the legally marketed predicate device (Roche CK-MB assay K003158). The study aimed to demonstrate that the new device's measurements are substantially equivalent to those of the predicate device. For the imprecision and AMR studies, the ground truth is implicitly the inherent biological measurement of the samples at various concentrations using the new device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device that requires a training set in that sense. It is a chemical assay.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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K Number

K083602

Device Name

KAPPA LIGHT CHAINS

Manufacturer

Date Cleared

2009-09-03

(272 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K964260

Intended Use

The Kappa light chains assay is an in vitro diagnostic test used for the quantitative determination of immunoglobulin bound and free kappa light chains (KAPPA) in serum and in Li-heparin plasma by immunoturbidimetry on Synchron LX20 System. Measurement of type of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus, in conjunction with other clinical and laboratory findings.

Device Description

The Kappa light chains assay is an in vitro diagnostic test used for the quantitative determination of immunoglobulin bound and free kappa light chains (KAPPA) in serum and in Li-heparin plasma by immunoturbidimetry on Synchron LX20 System. The determination of Kappa light chains is based on the specific turbidimetric reaction, which occurs between a polyclonal antiserum against human Immunoglobulin Kappa light chains and its corresponding antigen under optimal pH conditions and in the presence of polyethylene glycol (PEG). The turbidity of the immune complex is proportional to the concentration of the analyte in the sample.

AI/ML Overview

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

Device: Kappa light chains assay (Sentinel)

Predicate Device: Beckman IMMAGE Immunochemistry System Kappa light chain (K964260)

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device, primarily through performance similarities rather than explicit, pre-defined quantitative acceptance criteria with thresholds for accuracy, sensitivity, or specificity against a clinical ground truth. The acceptance is implied by acceptable correlation and precision compared to its own internal metrics and the overall 'similar performance characteristics' to the predicate.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison (Correlation with Predicate)	"Acceptable correlation" with Beckman Kappa light chain (K964260) on IMMAGE nephelometer Analyzer.	Correlation coefficient (r): 0.985
	Slope (implied close to 1)	Slope: 0.900
	Y-intercept (implied close to 0)	Y-intercept: 134 mg/dL
Precision (Total Imprecision)	"Acceptable" %CV values.	Ranges from 2.4% to 6.8% CV across 6 levels.
Precision (Between Days)	"Acceptable" %CV values.	Ranges from 1.7% to 5.5% CV across 6 levels.
Precision (Repeatability)	"Acceptable" %CV values.	Ranges from 1.5% to 4.1% CV across 6 levels.
Analytical Measurement Range (AMR) - Lower Limit	Not explicitly stated but expected to be within a clinically relevant range.	Found lower limit: 31.2 mg/dL. Claimed: 35 mg/dL.
Analytical Measurement Range (AMR) - Upper Limit	Not explicitly stated but expected to be within a clinically relevant range.	Found upper limit: 750.13 mg/dL. Claimed: 750 mg/dL.

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

Method Comparison: The document states "Comparative performance studies were conducted," but does not explicitly mention the sample size of patient samples used for the method comparison study. It does mention that the Kappa light chains assay on Synchron LX20 System was compared using "calibrator material with assigned Kappa Light chains concentration based on definition of Kappa Light chains as Whole IgG content (MW 150000)." This suggests that at least part of the comparison involved characterized calibrator samples rather than solely patient samples.
Precision Studies: Two levels for 20x2x2 test (day x run x rep) on 6 levels implies:
- 20 days x 2 runs/day x 2 replicates/run = 80 measurements for each of the 6 levels.
- Total tests for precision: 6 levels * 80 tests/level = 480 tests.
AMR Studies: Not explicitly stated.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

This type of in-vitro diagnostic (IVD) device (quantitative biochemical assay) does not typically rely on "experts" to establish ground truth in the same way an imaging or pathology device might. The "ground truth" for method comparison is the measurement obtained by the predicate device (Beckman IMMAGE Immunochemistry System Kappa light chain), which is itself a quantitative assay.

4. Adjudication Method for the Test Set

Not applicable. This is a comparison of quantitative measurements between two instruments/assays, not an interpretation that requires adjudication (like reading medical images).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices where human readers interpret outputs (e.g., medical images), and the AI either assists or replaces human interpretation. This device is a quantitative diagnostic assay.

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

Yes, the studies presented (method comparison, precision, AMR) are all standalone performance evaluations of the device (Kappa light chains assay on Synchron LX20 System). There is no "human-in-the-loop" component described for its operation or result generation; it's an automated in vitro diagnostic test system.

7. The Type of Ground Truth Used

The primary "ground truth" for the method comparison study was the measurements obtained from the predicate device (Beckman IMMAGE Immunochemistry System Kappa light chain, K964260). For precision and AMR, the ground truth refers to the intrinsic analytical performance characteristics of the new device itself, often evaluated against known concentrations or through repeated measurements, rather than an external clinical "ground truth" (e.g., pathology or outcomes data). The assays are also traceable to ERM-DA 470 (European Reference Material) from BCR (EG Community Bureau of Reference), corresponding to RPPHS (Reference Preparation for Protein in Human Serum), which serves as a metrological ground truth for standardization.

8. The Sample Size for the Training Set

The document does not specify a separate training set. For IVD submissions like this, the development process for an assay involves calibration and optimization, but typically, the pre-market submission focuses on the validation or test data for the final, locked-down assay. If there was an implicit "training" or development phase, the data used for that is not explicitly detailed as a distinct 'training set' in the context of machine learning.

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

As no explicit "training set" is mentioned in the context of machine learning, this question isn't directly applicable. The assay's development (which could be considered analogous to training) would involve establishing appropriate calibration curves and reagent formulations based on known standards and reference materials (e.g., ERM-DA 470).

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K Number

K083601

Device Name

LAMBDA LIGHT CHAINS

Manufacturer

SENTINEL PLASMAPROTEINS CAL 3X

Date Cleared

2009-06-22

(199 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K964260

Intended Use

The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. Measurement of the different types of light chains aids in the diagnosis of multiple myeloma. Iymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins) and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus in conjunction with other clinical and laboratory findings.

Device Description

The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. The determination of Lambda light chains is based on the specific turbidimetric reaction, which occurs between a polyclonal antiserum against human Immunoglobulin Lambda light chains and its corresponding antigen under optimal pH conditions and in the presence of polyethylene glycol (PEG). The turbidity of the immune complex is proportional to the concentration of the analyte in the sample.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Method Comparison	Acceptable correlation with predicate device (Beckman IMMAGE Lambda light chain, K964260)	Correlation coefficient (r) = 0.981
		Slope = 0.928
		Y-intercept = 58.59 mg/dL
Precision (Total CV%)	Not explicitly stated, but typical regulatory expectations for assays of this type are excellent to good precision.	Varies by concentration level:
		67.7 mg/dL: 4.7%
		243.6 mg/dL: 2.9%
		168.7 mg/dL: 3.4%
		387.0 mg/dL: 4.3%
		415.9 mg/dL: 4.3%
Analytical Measurement Range (AMR)	Not explicitly stated as a numerical criterion for acceptance, but a claimed range is provided.	Lower limit found: 20 mg/dL
		Upper limit found: 423 mg/dL
		Claimed AMR: 20 to 400 mg/dL

Study Details:

The primary study conducted was a performance characteristic study for the Lambda light chains assay on the Synchron LX20 System. The goal was to demonstrate substantial equivalence to a predicate device, the Beckman IMMAGE Immunochemistry System Lambda light chain (K964260).

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

Test Set Sample Size: The document does not explicitly state the total number of patient samples used for the method comparison study. It only mentions that precision studies were conducted on "5 levels (N=80 for each level)," totaling 400 precision test samples. For method comparison, it refers to "acceptable correlation," implying a comparison of results from unknown patient samples run on both devices.
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

This type of study (in vitro diagnostic assay verification) does not typically involve human experts establishing "ground truth" in the same way an image analysis or diagnostic AI study would. The ground truth for this assay is the quantitative concentration of Lambda light chains, as determined by the accepted scientific methods and calibration standards.

For the method comparison, the "truth" for the comparison samples would have been the results obtained from the predicate device (Beckman IMMAGE Immunochemistry System Lambda light chain). The predicate device itself (K964260) would have undergone its own validation to establish its accuracy.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic assay comparing quantitative measurements to a predicate device, there is no human adjudication process involved in establishing the "ground truth" for individual test results. The comparison is based on numerical agreement and statistical correlation.

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 study or an imaging study involving human readers. It's an in vitro diagnostic assay.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the device performance described (method comparison, precision, AMR) represents the standalone performance of the Lambda light chains assay on the Synchron LX20 System. It measures the analytical capabilities of the assay itself, independent of a human interpretation loop required for diagnostic imaging or similar applications.

7. The Type of Ground Truth Used

The ground truth for the method comparison was established by the results from the legally marketed predicate device (Beckman IMMAGE Immunochemistry System Lambda light chain, K964260). The predicate device's results are considered the established "truth" for the purpose of demonstrating substantial equivalence of the new device.

For the assay's own internal calibration and reference, it is stated that "Both assays are traceable to ERM-DA 470 (European Reference Material) from BCR (EG Community Bureau of Reference), corresponding to RPPHS (Reference Preparation for Protein in Human Serum)." This indicates the use of certified reference materials and established scientific standards to define the quantitative values.

8. The Sample Size for the Training Set

Not applicable in the context of this traditional in vitro diagnostic assay. There isn't a "training set" in the machine learning sense. The assay is developed and validated based on chemical and immunological principles, not by training an algorithm on a dataset. The calibration material used ("calibrator material with assigned Lambda Light chains concentration based on definition of Lambda Light chains as Whole IgG content (MW 150000)") could be considered analogous, but it's not a "training set" in the AI sense.

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

Not applicable for a "training set" in the AI sense. For the calibrator material, its "ground truth" or assigned concentration is established by its traceability to ERM-DA 470 and RPPHS (Reference Preparation for Protein in Human Serum), which are internationally recognized reference materials.

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K Number

K081533

Device Name

Manufacturer

Date Cleared

2008-06-25

(23 days)

Product Code

JIX

Regulation Number

862.1150

Type

Panel

MULTIGENT CREATININE (ENZYMATIC) ASSAY

Reference & Predicate Devices

K051457,K011226

Intended Use

Clinical Chemistry - The Sentinel Plasmaproteins Cal 3x is a device intended for medical purposes for use in Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M assays, to establish points of reference that are used in the determination of values in the measurement of Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid 1 - Antitrypsin, Glycoprotein, Alpha Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in human serum and plasma.
Sentinel Plasmaproteins Cal 3x must only be used for the calibration of plasmaprotein tests with the immunoturbidimetric methods.

Device Description

The Sentinel Plasmaproteins Cal 3x is a liquid, ready-to-use calibrator prepared from plasmatic plasmaproteins in human-based serum. It consists of 4 x 1 mL bottles of aqueous material containing Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in a human serum matrix. This material, when stored as directed, is stable until the date printed on the label. Calibrator traceability was stated as certificated to CRM 470 (Certified Reference Material), renamed ERM-DA 470 (European Reference Materials).

AI/ML Overview

This looks like a submission for an In Vitro Diagnostic (IVD) device, specifically a calibrator for plasmaprotein assays. The provided text describes the device and its modifications, not a study evaluating an AI-powered diagnostic device in the traditional sense (e.g., image-based diagnosis). Therefore, many of the requested elements for an AI study (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set, etc.) are not applicable to this type of submission.

However, I can extract the relevant information regarding the acceptance criteria and the "study" (validation process) for this calibrator to demonstrate its substantial equivalence.

Here's the information based on the provided text, with clarifications where the requested AI study elements do not apply:

Acceptance Criteria and Device Performance for Sentinel Plasmaproteins Cal 3X

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sentinel Plasmaproteins Cal 3x calibrator relate to the expected range for the target values of each analyte when calibrated. The "reported device performance" is essentially the determination that the calibrated values fall within these specified ranges after the validation process.

Analyte	Acceptance Criteria (Target Value Range) (mg/dL)	Reported Device Performance (Implied: Within Range)
alpha 1-Acid Glycoprotein	From 176 to 254	Within Range
Albumin	From 9344 to 14016	Within Range
Alpha 1-Antitrypsin	From 334 to 454	Within Range
Ceruloplasmin	From 66 to 124	Within Range
Haptoglobin	From 272 to 366	Within Range
Immunoglobulin A	From 478 to 718	Within Range
Immunoglobulin G	From 2264 to 3396	Within Range
Immunoglobulin M	From 204 to 3396	Within Range
Kappa	From 508 to 762	Within Range
Lambda	From 306 to 458	Within Range
Transferrin	From 580 to 872	Within Range

Additional Performance Criteria for Accepting a Single Run:

Results of normal and abnormal approved control materials are within the expected ranges.
The % recovery of Internal Calibrator Master Lot is within 97% - 103%.

Criteria for Target Value Determination:

Absence of outliers (single data - Mean > 3SD).
Imprecision less than 5%.
The obtained mean must be the Target value.

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

This is an IVD calibrator, not an AI diagnostic device that uses a "test set" of patient data in the typical sense.

Sample Size for Testing: For the validation of the calibrator, aliquots of the Plasmaproteins Cal 3x to be tested were analyzed in triplicate during each testing run. For each analyte, three (3) analytical runs were performed on at least two (2) different days.
Data Provenance: The calibrator is prepared from plasmatic plasmaproteins in human-based serum. The exact country of origin for the human serum is not specified, but the submission is from Milan, Italy. The testing described is prospective, as it involves laboratory analysis of the manufactured calibrator.

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

This is not applicable as this is an IVD calibrator. "Ground truth" for this device refers to the certified reference materials and established laboratory methods used to assign values to the calibrator, not expert consensus on medical images or patient outcomes. The traceability of the calibrator was stated as certificated to CRM 470 (Certified Reference Material), renamed ERM-DA 470 (European Reference Materials), which represents a highly standardized "ground truth" for analytical measurements.

4. Adjudication Method for the Test Set

Not applicable for an IVD calibrator. The "adjudication" is based on adherence to established quality control ranges, % recovery of internal calibrators, and statistical checks for outliers and imprecision as described in point 1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for an IVD calibrator. The submission focuses on demonstrating substantial equivalence to predicate calibrators and validating the assigned values through laboratory testing.

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

While the device itself operates without human intervention once the assays are set up, the concept of "standalone performance" as typically applied to AI algorithms (i.e., algorithm only without human interaction) is not applicable here. The device is a calibrator, which is a component in a larger analytical process; its performance is intrinsically linked to the assays and instruments it calibrates. The "standalone" aspect would be its ability to consistently provide accurate reference points.

7. The Type of Ground Truth Used

The ground truth for the analyte values in the calibrator is established by traceability to certificated reference materials (CRM 470 / ERM-DA 470), which provides highly accurate and internationally recognized standards for the quantification of these plasma proteins. This is complemented by an "Internal Calibrator Master Lot" used in the calibration process.

8. The Sample Size for the Training Set

Not applicable. This is an IVD calibrator, not an AI algorithm that undergoes "training." The "training" of the analytical process would involve setting up and validating the immunoturbidimetric assays on specific instruments according to manufacturer protocols, using the reference materials.

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

Not applicable. As above, this is an IVD calibrator. The "ground truth" for the overall analytical process (which the calibrator is a part of) is established through certified reference materials and validated immunoassay methodologies. The target value assignment procedure for the calibrator itself is described as being in internal SOPs and under defined conditions, utilizing the mentioned CRMs and an Internal Calibrator Master Lot.

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K Number

K073634

Device Name

Manufacturer

Date Cleared

2008-06-19

(176 days)

Product Code

JFY

Regulation Number

862.1225

Type

Panel