Search Results

The ENZ 1 CAL is an in vitro diagnostic product for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase (PCHE) methods on the Dimension Vista™ System.

ENZ 1 CAL is a liquid, multi-analyte, bovine serum albumin based product containing amylase (human saliva), gamma-glutamyl transferase (bovine kidney), lactate dehydrogenase (chicken heart), Iipase (porcine pancreas), and pseudocholinesterase (horse serum), The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation tis required). The volume per vial is 2.5 mL.

The provided text describes the Dimension Vista™ System Enzyme 1 Calibrator (ENZ 1 CAL - KC310), an in vitro diagnostic product used for the calibration of specific enzyme methods on the Dimension Vista™ System.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document primarily focuses on the stability and traceability of the calibrator, which are key performance characteristics for such a device. The "acceptance criteria" are implied by the targets and allowable ranges for these characteristics.

• ≤ 7% for lipase
• ≤ 5% for amylase, gamma-glutamyl transferase, lactate dehydrogenase, and pseudocholinesterase. | "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc." (This implies the device met the criteria, but the specific data/results are not tabulated in the provided text). |
  | On-Board Stability | 7 days (vial punctured by instrument and stored on board). | "A vial punctured by the instrument and stored on board has a seven day stability claim." (This indicates the claim is supported, implying performance meets this criterion). |
  | Open-Vial Stability | 31 days (vial recapped and stored in refrigerator, not on instrument). | "An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 31 days." (This indicates the claim is supported, implying performance meets this criterion). |
  | Traceability | Assigned values traceable to Master Pool, Dimension® clinical chemistry system. | "The assigned values of the Enzyme 1 Calibrator are traceable to Master Pool, Dimension® clinical chemistry system."
  "LIP Anchor Pool values are assigned using an external reference system (PBS/Precical®)."
  "The stock solution is verified by comparing the recovery of the stock solution versus the Master Pool assigned bottle values."
  "The concentration of each level is verified to be within acceptable range by using an instrument calibrated with Master Pools. The final bottle value is assigned to each level and verified on multiple instruments for N > 40 total replicates using a released commercial lot of calibrator as a control." (This outlines the system for ensuring traceability). |
  | Bottle Value Assignment| Calibration values for AMY, GGT, LDH, PCHE (levels 2 & 3) assigned on multiple instruments using fixed coefficients.
  LIP Master Pool bottle values (levels 2, 3, 4) assigned on multiple instruments calibrated with LIP Anchor Pool.
  Concentration of each level verified to be within acceptable range.
  Final bottle value assigned and verified on multiple instruments with N > 40 total replicates per level using a commercial lot calibrator as control. | "Master Pool level 1 of BSA base is assigned value 0 U/L."
  "LIP Master Pool bottle values levels 2, 3, and 4 are assigned on multiple instruments calibrated with LIP Anchor Pool. The LIP Anchor Pool values are assigned using an external reference system (PBS/Precical®)."
  "AMY, GGT, LDH and PCHE bottle values for levels 2 and 3 are assigned on multiple instruments using fixed coefficients. N > 40 total replicates per level. A previous Master Pool lot is used as a control."
  "The stock solution is verified by comparing the recovery of the stock solution versus the Master Pool assigned bottle values."
  "The concentration of each level is verified to be within acceptable range by using an instrument calibrated with Master Pools. The final bottle value is assigned to each level and verified on multiple instruments for N > 40 total replicates using a released commercial lot of calibrator as a control." |

2. Sample size used for the test set and the data provenance:

• Test Set (Verification of bottle values): For AMY, GGT, LDH, and PCHE bottle values (levels 2 and 3), "N > 40 total replicates per level" were used. For the final bottle value assignment and verification, "N > 40 total replicates" were used.
• Data Provenance: The studies were conducted by Dade Behring Inc. as part of their regulatory submission for a diagnostic calibrator. This implies the data is from their internal testing and validation processes. The country of origin is implicitly the USA, where Dade Behring Inc. is located and where the FDA review took place. The studies are prospective in nature, as they involve testing the performance of the newly developed calibrator.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is a calibrator material, not a diagnostic device that interprets clinical images or patient data. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists, pathologists) does not apply.
• The ground truth for the calibrator's values is established by a hierarchical traceability system to Master Pools and, for LIP, to an external reference system (PBS/Precical®). This process involves highly controlled laboratory procedures, skilled personnel, and established analytical methods. While specific numbers and qualifications of individual "experts" are not provided, it's implicitly through the rigorous quality control and measurement processes within Dade Behring's laboratories.

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

• Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., images). This is not applicable to a calibrator material where values are determined through analytical measurements.
• The "adjudication" is inherent in the multi-instrument testing and the comparison against Master Pools and control lots. For example, "AMY, GGT, LDH and PCHE bottle values for levels 2 and 3 are assigned on multiple instruments... N > 40 total replicates per level. A previous Master Pool lot is used as a control." This implies a comparison and verification process rather than an adjudication of subjective interpretations.

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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., medical imaging AI). The device described is a calibrator material, not an AI-assisted diagnostic tool.

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

• This question is not applicable. The device is a calibrator, not an algorithm. The performance described relates to its analytical accuracy and stability when used with the Dimension Vista™ System.

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

• The ground truth for the calibrator's assigned values is established through a traceability chain to Master Pools and, for lipase (LIP), an external reference system (PBS/Precical®).
• These Master Pools and reference systems represent well-characterized analytical standards, ensuring the accuracy and consistency of the calibrator's values. This is an analytical ground truth based on highly controlled measurement and reference materials.

8. The sample size for the training set:

• This concept is not applicable as this is a calibrator material, not a machine learning model that undergoes training. The values are assigned based on analytical measurements and traceability to reference materials.

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

• Not applicable as there is no "training set" in the context of this calibrator device. The "ground truth" (assigned values) for the calibrator is established through the robust analytical and traceability methods described in point 7.

Ask a specific question about this device

The Glucose Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure glucose in blood and other body fluids. 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.

The Glucose Flex® reagent cartridge (GLUC) for the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of glucose in human serum, plasma, urine, and cerebrospinal fluid. The technology is Enzymatic: Hexokinase- glucose-6 phosphate dehydrogenase. Detection is Bichromatic endpoint measurement- NADH (340 & 383 nm). Reaction Time is 120 seconds. Reagents are Liquid.

Here's a breakdown of the acceptance criteria and study details for the Glucose Flex® reagent cartridge (GLUC) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific slope, intercept, or correlation coefficient ranges. However, the study aims to demonstrate substantial equivalence to the predicate device (GLU Flex® reagent cartridge) through split-sample comparison. The reported performance is presented as correlation statistics.

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

• Sample Size for Test Set:
  • Serum/Plasma: 162 samples
  • Urine: 64 samples
  • Cerebrospinal Fluid: 70 samples
• Data Provenance: The data used was from "clinical patient samples." The country of origin is not specified, but given the submitter (Dade Behring Inc., Newark, DE) and the FDA submission, it can be inferred to be from the United States or a region with similar clinical practices. The data is retrospective as it involves "clinical patient samples" that were already collected and tested for the comparison.

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

This information is not provided in the document. For in vitro diagnostic devices like glucose test systems, the "ground truth" for the test set is typically established by comparing the device's results to a well-established, highly accurate reference method or a legally marketed predicate device. The document explicitly states a "split sample comparison" with the predicate device, implying the predicate device serves as the reference, but it doesn't mention human experts establishing ground truth for individual samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this type of study. Adjudication methods like 2+1 or 3+1 are typically used in imaging or clinical trial settings where human interpretation of results might vary. For a quantitative in vitro diagnostic device comparing its performance to a predicate, the comparison is direct numerical data.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers (e.g., AI in radiology). The Glucose Flex® reagent cartridge is an in vitro diagnostic test system that provides a quantitative measurement directly, without human interpretation in the same way an imaging study would require.

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

This is an inherently standalone device. The "algorithm" here is the enzymatic reaction and detection process within the clinical chemistry system. The performance presented (correlation statistics) represents the device's measurement capabilities directly, without a human-in-the-loop to interpret or modify its output as part of the primary measurement.

7. The Type of Ground Truth Used

The ground truth for this study was established using comparison to a legally marketed predicate device, specifically the "GLU Flex® reagent cartridge also on the Dimension® clinical chemistry system." The "split sample comparison" means that portions of the same patient samples were tested on both the new device (GLUC) and the predicate device (GLU), and the results were then statistically compared.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set. For in vitro diagnostic devices like this, the development process might involve internal studies and method optimization, but a distinct "training set" with established ground truth as understood in machine learning contexts is typically not described in these 510(k) summaries for chemical analyzers. The provided data is for the performance evaluation that supports the 510(k) submission.

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

As no training set is described, this information is not applicable/provided.

Ask a specific question about this device