(49 days)
No
The document describes a calibration product for in vitro diagnostic tests and does not mention any AI or ML components.
No
The device is described as 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", indicating it is used for diagnostic purposes, not for treating a disease or condition.
No
Explanation: This device is a calibrator for in vitro diagnostic products, not a diagnostic device itself. It helps to ensure the accuracy of diagnostic tests by providing known concentrations of analytes.
No
The device is a liquid, multi-analyte, bovine serum albumin based product containing various enzymes. It is a physical calibrator kit, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the ENZ 1 CAL is an "in vitro diagnostic product".
- Function: Its purpose is for the calibration of methods used to measure specific analytes (Amylase, GGT, LDH, Lipase, and PCHE) in biological samples on a diagnostic system (Dimension Vista™ System). Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests.
- Device Description: The description details the composition of the product, which is a liquid, multi-analyte, bovine serum albumin based product containing various enzymes. These are the components used in the in vitro diagnostic process.
Therefore, based on the provided information, the ENZ 1 CAL clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 (LIP), and Pseudocholinesterase (PCHE) methods on the Dimension Vista™ System.
Product codes
JIX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- Stability: Target shelf life for the Dimension Vista™ Enzyme 1 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4°C with control stored at -70°C. The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined where the allowable shelf life percent change should be ≤ 7 % for lipase and ≤ 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. A vial punctured by the instrument and stored on board has a seven day stability claim. An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 31 days. For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2-8 °C. Opened/punctured vials are tested on days 3, 8, 15, 22, and 32 versus freshly opened vials.
- Traceability: The assigned values of the Enzyme 1 Calibrator are traceable to Master Pool, Dimension® clinical chemistry system.
- 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. 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.
Key Metrics
Allowable shelf life percent change should be ≤ 7 % for lipase and ≤ 5 % for amylase, gamma-glutamyl transferase, lactate dehydrogenase, and pseudocholinesterase.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
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), Lactate
Dehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase
(PCHE). |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C. Type of Test: | Calibrator Material |
| D. Applicant: | Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101
Victor M. Carrio, Regulatory Affairs and Compliance Manager
Office: (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:
-
- Regulation section: 21 CFR § 862-1150 Calibrator
-
- Classification: Class II
-
- Product Code: JIX Calibrator, Multi-Analyte Mixture
-
- 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:
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.
1
| Item | Device
Dimension Vista™
System Enzyme 1
Calibrator | Dimension® Enzyme Verifier
K860021 | Predicate Devices
Dimension® Lipase
Calibrator
K952815 | Dimension® PCHE Verifier
K883891 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ENZ I 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. | Enzyme Verifier is an in vitro
diagnostic product to be used to
verify Alkaline Phosphatase
(ALP), Amylase (AMY), G-
Glutamyl Transferase (GGT),
Aspartame Aminotransferase
(AST), Alanine Aminotransferase
(ALT) and Lactic Dehydrogenase
(LDH) method performance on the
Dimension® clinical chemistry
system. | The Lipase Calibrator is an in
vitro diagnostic product to be
used to calibrate the
Dimension® clinical chemistry
systems for the Lipase (LIP)
method. | The Dimension®
Pseudocholinesterase Verifier is an
in vitro diagnostic product to be
used to verify the Dimension®
clinical chemistry system for the
Pseudocholinesterase (PCHE)
method. |
| Analytes | Amylase (AMY)
Gamma-Glutamyl
Transferase (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® clinical
chemistry system
values. | Master Pool, Dimension® clinical
chemistry system values. | Master Pool, Dimension® clinical
chemistry system values. | Master Pool, Dimension® clinical
chemistry system values. |
| Matrix | Bovine serum base with
amylase (human saliva),
GGT (bovine kidney) | Human serum base with amylase
(porcine pancreas), GGT (bovine
kidney) and LDH (bovine heart) | Human serum with lipase
(porcine pancreas). | Human serum and bovine serum
albumin base product. |
| Item | Device | Predicate Devices | Number of Levels | |
| Dimension Vista™
System Enzyme 1
Calibrator | LDH (chicken heart),
lipase (porcine
pancreas), and PCHE
(horse serum). | | Two levels. | |
| | Dimension® Enzyme Verifier
K860021 | | Three levels. | |
| | Dimension® Lipase
Calibrator
K952815 | | Three levels. | |
| | Dimension® PCHE Verifier
K883891 | | Three levels. | |
bstantial Equivalence Information
I.
2
:
3
J. Standard/Guidance Document Referenced:
medical devices
| 1. Guidance: | Guidance for Industry - Abbreviated 510(k) Submissions for In
Vitro Diagnostic Calibrators; Final, 02/22/1999
Guidance for Industry and FDA Staff - Use of Symbols on Labels
and in Labeling of In Vitro Diagnostic Devices Intended for
Professional Use, 11/30/2004 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Standards: | CEN 13640 Stability testing of In-Vitro Diagnostic Devices
ISO 14971:2000 Medical devices -Application of risk management to |
K. Performance Characteristics:
| 1. Stability: | Target shelf life for the Dimension Vista™ Enzyme 1 Calibrator is
12 months. Calibrator shelf life is determined by comparing
results of the product stored at 4°C with control stored at -70°C.
The method is calibrated from this stored material. The 4°C
material values are recovered versus the calibration. Recovery
versus time is monitored and percent change over time is
determined where the allowable shelf life percent change should be
≤ 7 % for lipase and ≤ 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.
A vial punctured by the instrument and stored on board has a seven
day stability claim.
An open vial not on instrument, but recapped and stored in a
refrigerator has a stability claim of 31 days.
For testing, vials are opened /punctured on day zero. A quantity
sufficient for multiple calibrations is removed and the vials are
recapped and stored at 2-8 °C. Opened/punctured vials are tested
on days 3, 8, 15, 22, and 32 versus freshly opened vials. |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Traceability: | The assigned values of the Enzyme 1 Calibrator are traceable to
Master Pool, Dimension® clinical chemistry system. |
-
- 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.
- Bottle Value Assignment:
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