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.

Device Description

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.

AI/ML Overview

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.

Performance Characteristic	Acceptance Criteria (Target)	Reported Device Performance
Shelf-Life Stability	Target shelf life: 12 months. Allowable percent change over time for stored product (4°C vs. -70°C control): - ≤ 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.

Summary

{0}------------------------------------------------

Kou1923

510(k) Summary for the Dimension Vista™ System Enzyme 1 Calibrator (ENZ 1 CAL - KC310)

AUG 2 5 2006

A. 510(k) Number:

B. Analytes:	Amylase (AMY), Gamma-Glutamyl Transferase (GGT), LactateDehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase(PCHE).
C. Type of Test:	Calibrator Material
D. Applicant:	Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101Victor M. Carrio, Regulatory Affairs and Compliance ManagerOffice: (302) 631-0376 Fax: (302) 631-6299

E. Proprietary and Established Names:

Dimension Vista™ System Enzyme 1 Calibrator (ENZ 1 Cal-KC310)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862-1150 Calibrator
1. Classification: Class II
1. Product Code: JIX Calibrator, Multi-Analyte Mixture
1. Panel: Clinical Chemistry
The ENZ 1 CAL is an in vitro diagnostic product for the G. Intended Use: calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase (PCHE) methods on the Dimension Vista™ System.

H. Device Description:

{1}------------------------------------------------

Item	DeviceDimension Vista™System Enzyme 1Calibrator	Dimension® Enzyme VerifierK860021	Predicate DevicesDimension® LipaseCalibratorK952815	Dimension® PCHE VerifierK883891
Intended Use	The ENZ I CAL is anin vitro diagnosticproduct for thecalibration of Amylase(AMY), Gamma-Glutamyl Transferase(GGT), LactateDehydrogenase (LDH),Lipase (LIP), andPseudocholinesterase(PCHE)methods on theDimension Vista™System.	Enzyme Verifier is an in vitrodiagnostic product to be used toverify Alkaline Phosphatase(ALP), Amylase (AMY), G-Glutamyl Transferase (GGT),Aspartame Aminotransferase(AST), Alanine Aminotransferase(ALT) and Lactic Dehydrogenase(LDH) method performance on theDimension® clinical chemistrysystem.	The Lipase Calibrator is an invitro diagnostic product to beused to calibrate theDimension® clinical chemistrysystems for the Lipase (LIP)method.	The Dimension®Pseudocholinesterase Verifier is anin vitro diagnostic product to beused to verify the Dimension®clinical chemistry system for thePseudocholinesterase (PCHE)method.
Analytes	Amylase (AMY)Gamma-GlutamylTransferase (GGT)Lactate Dehydrogenase(LDH)Lipase (LIP)Pseudocholinesterase(PCHE).	Alkaline Phosphatase (ALP)Amylase (AMY)Gamma-Glutamyl Transferase(GGT)Aspartame Aminotransferase(AST)Alanine Aminotransferase (ALT)Lactic Dehydrogenase (LDH)	Lipase (LIP).	Pseudocholinesterase (PCHE).
Form	Liquid.	Lyophilized.	Lyophilized.	Lyophilized.
Traceability	Master Pool,Dimension® clinicalchemistry systemvalues.	Master Pool, Dimension® clinicalchemistry system values.	Master Pool, Dimension® clinicalchemistry system values.	Master Pool, Dimension® clinicalchemistry system values.
Matrix	Bovine serum base withamylase (human saliva),GGT (bovine kidney)	Human serum base with amylase(porcine pancreas), GGT (bovinekidney) and LDH (bovine heart)	Human serum with lipase(porcine pancreas).	Human serum and bovine serumalbumin base product.
Item	Device	Predicate Devices	Number of Levels
Dimension Vista™System Enzyme 1Calibrator	LDH (chicken heart),lipase (porcinepancreas), and PCHE(horse serum).		Two levels.
	Dimension® Enzyme VerifierK860021		Three levels.
	Dimension® LipaseCalibratorK952815		Three levels.
	Dimension® PCHE VerifierK883891		Three levels.

bstantial Equivalence Information

{2}------------------------------------------------

{3}------------------------------------------------

J. Standard/Guidance Document Referenced:

medical devices

1. Guidance:	Guidance for Industry - Abbreviated 510(k) Submissions for InVitro Diagnostic Calibrators; Final, 02/22/1999Guidance for Industry and FDA Staff - Use of Symbols on Labelsand in Labeling of In Vitro Diagnostic Devices Intended forProfessional Use, 11/30/2004
2. Standards:	CEN 13640 Stability testing of In-Vitro Diagnostic DevicesISO 14971:2000 Medical devices -Application of risk management to

K. Performance Characteristics:

1. Stability:	Target shelf life for the Dimension Vista™ Enzyme 1 Calibrator is12 months. Calibrator shelf life is determined by comparingresults of the product stored at 4°C with control stored at -70°C.The method is calibrated from this stored material. The 4°Cmaterial values are recovered versus the calibration. Recoveryversus time is monitored and percent change over time isdetermined where the allowable shelf life percent change should be≤ 7 % for lipase and ≤ 5 % for amylase, gamma-glutamyltransferase, lactate dehydrogenase, and pseudocholinesterase.Shelf-life stability (expiration) dating assignment atcommercialization reflects the real-time data on file at DadeBehring, Inc.A vial punctured by the instrument and stored on board has a sevenday stability claim.An open vial not on instrument, but recapped and stored in arefrigerator has a stability claim of 31 days.For testing, vials are opened /punctured on day zero. A quantitysufficient for multiple calibrations is removed and the vials arerecapped and stored at 2-8 °C. Opened/punctured vials are testedon days 3, 8, 15, 22, and 32 versus freshly opened vials.
2. Traceability:	The assigned values of the Enzyme 1 Calibrator are traceable toMaster Pool, Dimension® clinical chemistry system.

1. Stability:

Target shelf life for the Dimension Vista™ Enzyme 1 Calibrator is12 months. Calibrator shelf life is determined by comparingresults of the product stored at 4°C with control stored at -70°C.The method is calibrated from this stored material. The 4°Cmaterial values are recovered versus the calibration. Recoveryversus time is monitored and percent change over time isdetermined where the allowable shelf life percent change should be≤ 7 % for lipase and ≤ 5 % for amylase, gamma-glutamyltransferase, lactate dehydrogenase, and pseudocholinesterase.Shelf-life stability (expiration) dating assignment atcommercialization reflects the real-time data on file at DadeBehring, Inc.A vial punctured by the instrument and stored on board has a sevenday stability claim.An open vial not on instrument, but recapped and stored in arefrigerator has a stability claim of 31 days.For testing, vials are opened /punctured on day zero. A quantitysufficient for multiple calibrations is removed and the vials arerecapped and stored at 2-8 °C. Opened/punctured vials are testedon days 3, 8, 15, 22, and 32 versus freshly opened vials.

2. Traceability:

The assigned values of the Enzyme 1 Calibrator are traceable toMaster Pool, Dimension® clinical chemistry system.

1. Bottle Value Assignment:
  Bovine serum albumin (BSA) base is used as Level 1 for AMY, GGT, LDH, PCHE and LIP and stored at -70°C. AMY, GGT, LDH and PCHE are added gravimetrically to BSA base to target concentrations for levels 2 and 3 and stored at -70°C. Dimension® LIP Master Pools in human serum are used for levels 2, 3 and 4 and stored at 2 - 8°C.

{4}------------------------------------------------

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.

To manufacture Enzyme 1 Calibrator, a stock solution is prepared by gravimetrically adding quantities of AMY, GGT, LDH, LIP, and PCHE to bovine serum albumin base to target concentrations. The stock solution is verified by comparing the recovery of the stock solution versus the Master Pool assigned bottle values. Calculated quantities of the stock solution are added to the bovine serum albumin base to target concentrations to produce the commercial calibrator lot. 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.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a single staff entwined by two snakes and topped with wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 5 2006

Mr. Victor M. Carrio Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714

Re: K061923

Trade/Device Name: Dimension Vista™ Enzyme 1 Calibrator (KC310) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 6, 2006 Received: July 7. 2006

Dear Mr. Carrio:

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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{6}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Alberto G.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications For Use Statement

510(k) Number (if known):

Device Name: K061923

Dimension Vista™ Enzyme 1 Calibrator (KC310)

Indications for Use:

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

Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(K) K061923

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.