Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a chemical calibrator for in vitro diagnostic tests and does not mention any AI or ML components or functionalities.

Therapeutic

No
Explanation: The device is described as an in vitro diagnostic product for calibration of various methods on a system, not for treating any medical condition.

Diagnostic

No.
The CHEM 1 CAL is described as an "in vitro diagnostic product for the calibration" of various methods, meaning it is used to calibrate an in vitro diagnostic device, not to directly diagnose.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a liquid, multi-analyte, bovine serum albumin based product, which is a physical substance, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The document explicitly states that the CHEM 1 CAL is an "in vitro diagnostic product for the calibration of..." various chemical methods. This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
Device Description: The description details a product used in a laboratory setting (on the Dimension VistaTM System) for calibrating tests that measure substances in biological samples (calcium, cholesterol, creatinine, etc.).
Intended User/Care Setting: The mention of "in vitro diagnostic product" further reinforces its intended use in a clinical or laboratory setting for diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (URCA) methods on the Dimension VistaTM System.

Product codes

JIX

Device Description

CHEM 1 CAL is a liquid, multi-analyte, bovine serum albumin based product containing calcium, cholesterol, creatinine, glucose. lactic acid, magnesium, thyroxine, urea nitrogen and uric acid. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Stability:
Target shelf life for the Dimension Vista™ Chemistry 1 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4°C with control stored at -20°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 less than or equal to:

Urea Nitrogen: ≤ 5%.
Calcium: ≤ 5 %
Cholesterol: ≤ 3%
Creatinine: ≤ 5%
Glucose: ≤ 5%
Lactic Acid: ≤ 5%
Magnesium: ≤ 3%
Thyroxine: ≤ 6%
Thyroxine Uptake: ≤ 6%
Uric Acid: ≤ 5%

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 stability claim of one day. An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 30 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 0, 8 hrs, 2, 8, 31 versus freshly opened vials.

Traceability:
The assigned values of the Chemistry 1 Calibrator are standardized to the enclosed table of assigned values:

BUN: NIST SRMa 912
CA: NIST SRM 915
CHOL: NIST SRM 911 (CDCb) Abell-Kendall reference method
CREA: NIST SRM 914
GLU: NIST SRM 917
LA: Lactic acid- lithium salt (A- Grade)
MG: NIST SRM 929 A
T4: USPc
TU: Calculated value
URCA: NIST SRM 913

Bottle Value Assignment:
Urea Nitrogen, calcium carbonate, creatinine, cholesterol. glucose, lactic acid, magnesium gluconate, uric acid, and thyroxine reference materials are weighed appropriate aqueous solutions or human serum traced to primary standard material. Master Pool and standards are stored frozen for each analyte. The verification of the Master Pool/Standard values are compared against previously approved Master Pool/Standard values. The stock solution is made by adding reference materials gravimetrically to stock solution at target concentrations. The stock solution values are verified versus previously approved Master Pool/Standard values. The commercial lot is made by adding calculated quantities of stock solution to base matrix in appropriate concentrations for two calibrator levels. The concentration of each level is verified by using an instrument calibrated with Master Pools. The final bottle values for each level of the commercial lot is assigned and verified using multiple instruments by testing N = 45 replicates.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K860021, K861700, K861700, K862359, K862359

Reference Device(s)

K051087

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

510(k) Summary for the Dimension Vista™ System Chemistry 1 Calibrator (CHEM 1 CAL - KC110)

A. 510(k) Number:

B. Analytes:

K061838

Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN)4 and Uric Acid (URCA).

AUG 2 1 2006

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 Chemistry 1 Calibrator (CHEM 1 CAL-KC110)

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

H. Device Description:

CHEM 1 CAL is a liquid, multi-analyte, bovine serum albumin based product containing calcium, cholesterol, creatinine, glucose.

G. Intended Use: The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) 1 and Uric Acid (URCA) methods on the Dimension Vista™ System.

1 The Dimension Vista™ System Chemistry 1 Calibrator was previously cleared for the calibration of blood urea nitrogen (BUN) in the Dimension Vista™ System under K051087.

1

lactic acid, magnesium, thyroxine, urea nitrogen and uric acid. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL. This same product, the Dimension Vista™ System Chemistry 1 Calibrator (KC110), was previously cleared (K051087) for the calibration of the Blood Urea Nitrogen (BUN) method on the Dimension Vista™ system.

2

ostantial Equivalence Informatio I

Item	Device	Predicate Devices
Intended
Use	Dimension Vista™
System Chemistry 1
Calibrator²	CHEM I
Calibrator
K860021
(URCA-K862359)	Chemistry II
Calibrator
K861700	Cholesterol
Calibrator
K861700	Thyroxine
Calibrator
K862359	Thyronine Uptake
Calibrator
K862359
	The CHEM 1 CAL is an
in vitro diagnostic
product for the calibration
of Calcium (CA),
Cholesterol (CHOL),
Creatinine (CREA),
Glucose (GLU), Lactic
Acid (LA), Magnesium
(MG), Thyroxine (T4),
Thyronine Uptake (TU),
Blood Urea Nitrogen
(BUN)² and Uric Acid
(URCA) methods on the
Dimension Vista™
System.	The Dimension®
Chemistry I
Calibrator is an in
vitro diagnostic
product to be used to
calibrate the
Dimension® clinical
chemistry system for
the Calcium (CA),
Creatinine (CREA),
Glucose
(GLU/GLUC), Lactic
Acid (LA), Urea
Nitrogen (BUN) and
Uric Acid (URCA)
methods.	CHEM II Calibrator
is an in vitro
diagnostic product to
be used to calibrate
the Dimension®
clinical chemistry
system for the
magnesium (MG),
phosphorus (PHOS)
and triglycerides
(TRIG) methods.	The Dimension®
Cholesterol Calibrator
is an in vitro
diagnostic product to
be used to calibrate the
Dimension® clinical
chemistry system for
the Cholesterol
(CHOL) method.	The Dimension®
Thyroxine Calibrator
is an in vitro
diagnostic product to
be used to calibrate the
Dimension® clinical
chemistry system for
the Thyroxine (T4)
method.	The Dimension®
Thyronine Uptake is
an in vitro diagnostic
product to be used to
calibrate the
Dimension® clinical
chemistry system for
the Thyronine Uptake
method.
Analytes	Calcium (CA),
Cholesterol (CHOL),
Creatinine (CREA),
Glucose (GLU), Lactic
Acid (LA), Magnesium
(MG), Thyroxine (T4),
Thyronine Uptake (TU),
Blood Urea Nitrogen
(BUN)² and Uric Acid
(URCA)	Calcium (CA),
Creatinine (CREA),
Glucose (GLU),
Lactic Acid (LA),
Urea Nitrogen (BUN)
and Uric Acid
(URCA).	Magnesium (MG).	Cholesterol (CHOL).	Thyroxyne (T4).	Thyronine Uptake
(TU).
Item	Device	Predicate Devices
	Dimension Vista™
System Chemistry 1
Calibrator²	CHEM I
Calibrator
K860021
(URCA–K862359)	Chemistry II
Calibrator
K861700	Cholesterol
Calibrator
K861700	Thyroxine
Calibrator
K862359	Thyronine Uptake
Calibrator
K862359
Form	Liquid.	Lyophilized.	Liquid.	Lyophilized.	Lyophilized.	Lyophilized.
Traceability	BUN – NIST SRM 912²
CA – NIST SRM 915.
CHOL – Abell-Kendall
(CDC-NCEP).
CREA – NIST SRM 914.
GLU – NIST SRM 917.
LA – Lactic acid – lithium
salt A-Grade.
MG – NIST SRM 929A.
T4 – USP.
TU – Calculated value.
URCA – NIST SRM 913.	BUN – NIST SRM
912
CA – NIST SRM 915.
CREA – NIST SRM

3

² The Dinansion Vista™ System Chemistry 1 Calbrator was previously cleared for the calbration of blood ura nimogen (BUN) in the Dimension Vista™ System
under K051087.

.

4

J. Standard/Guidance Document Referenced:

| 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
medical devices |

K. Performance Characteristics:

1. Stability: Target shelf life for the Dimension Vista™ Chemistry 1 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4°C with control stored at -20°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 less than or equal to:

Analyte	Allowable Shelf life percent change
Urea Nitrogen3	≤ 5%.
Calcium	≤ 5 %
Cholesterol	≤ 3%
Creatinine	≤ 5%
Glucose	≤ 5%
Lactic Acid	≤ 5%
Magnesium	≤ 3%
Thyroxine	≤ 6%
Thyroxine Uptake	≤ 6%
Uric Acid	≤ 5%

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 stability claim of one day.

An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 30 days.

For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are

3 The Dimension Vista™ System Chemistry 1 Calibrator was previously cleared for the calibration of blood urea nitrogen (BUN) in the Dimension Vista™ System under K051087.

5

recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 0, 8 hrs, 2, 8, 31 versus freshly opened vials.

The assigned values of the Chemistry 1 Calibrator are standardized 2. Traceability: to the enclosed table of assigned values:

Constituent	Traceability
BUN4	NIST SRMa 912
CA	NIST SRM 915
CHOL	NIST SRM 911
(CDCb) Abell-Kendall reference method
CREA	NIST SRM 914
GLU	NIST SRM 917
LA	Lactic acid- lithium salt (A- Grade)
MG	NIST SRM 929 A
T4	USPc
TU	Calculated value
URCA	NIST SRM 913

4 National Institute of Standards and Technology - Standard Reference Material. 6 Centers for Disease Control.

C United States Pharmacopeia.

1. Bottle Value Assignment:
  Urea Nitrogen, calcium carbonate, creatinine, cholesterol. glucose, lactic acid, magnesium gluconate, uric acid, and thyroxine reference materials are weighed appropriate aqueous solutions or human serum traced to primary standard material. Master Pool and standards are stored frozen for each analyte. The verification of the Master Pool/Standard values are compared against previously approved Master Pool/Standard values. The stock solution is made by adding reference materials gravimetrically to stock solution at target concentrations. The stock solution values are verified versus previously approved Master Pool/Standard values. The commercial lot is made by adding calculated quantities of stock solution to base matrix in appropriate concentrations for two calibrator levels. The concentration of each level is verified by using an instrument calibrated with Master Pools. The final bottle values for each level of the commercial lot is assigned and verified using multiple instruments by testing N = 45 replicates.

4 The Dimension Vista™ System Chemistry 1 Calibrator was previously cleared for the calibration of blood urea nitrogen (BUN) in the Dimension Vista™ System under K051087.

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor M. Carrio RA/OS Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714-6101

AUG 2 1 2006

Re: K061838

Trade/Device Name: Dimension Vista™ Chemistry 1 Calibrator (KC110) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: June 28, 2006 Received: June 29, 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).

7

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 yours,

Alberto Guts

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

8

Indications For Use Statement

510(k) Number (if known): K061838

Device Name:

Dimension Vista™ Chemistry 1 Calibrator (KC110)

Indications for Use:

The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (URCA) methods on the Dimension VistaTM 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)

Carl Benson
Division Sign-Off

Division Sign-On

ce of In Vitro Diagnost Evaluation and Safety

510(k) K061838