The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method on the Dimension® clinical chemistry system is for the quantitative determination of lidocaine in serum or plasma. Lidocaine measurements may be used in the diagnosis and treatment of lidocaine overdose and in therapeutic drug monitoring.

The Dade Behring Dimension® Drug Calibrator II (DC49D) is a device intended for medical purposes for use on the Dimension® clinical chemistry system to establish points of parfonob to are used in determination of values in the measurement of substances in human specimens.

Device Description

Method: The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® LIDO Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbition immunoassay (PETINIA) which uses a latex particle-lidocaine conjugate and monoclonal lidocaine specific antibody. Lidocaine present in the sample competes with lidocaine on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of lidocaine in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.

Calibrator: The Dade Behring Drug Calibrator 11 (DC49D) is liquid, bovine serum base product, packaged as ten vials to a carton, with two vials at each of five levels; each vial contains 5.0 mL. This same product, the Dade Behring Drug Calibrator II (DC49C), was previously cleared (K032574) for calibration of its associated methods on the Dimension® clinical chemistry system. The product remains unchanged except for the additional value assignment for the Lidocaine constituent.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details based on the provided text, formatted to address your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implicitly met by showing good agreement with the predicate. The performance is reported as a comparison to this predicate.

Feature / Metric	Acceptance Criteria (Implicitly met by demonstrating substantial equivalence to predicate)	Reported Device Performance (Dimension® LIDO Flex® vs. aca® LIDO)
Correlation Coefficient	High correlation (implicitly accepted as equivalent to predicate)	0.99
Slope	Close to 1.0 (implicitly accepted as equivalent to predicate)	0.985
Intercept	Close to 0 (implicitly accepted as equivalent to predicate)	-0.037 ug/mL
Intended Use	In vitro diagnostic use for quantitative determination of lidocaine in serum or plasma, used for diagnosis/treatment of overdose and therapeutic drug monitoring.	Matches predicate.
Assay Range	Comparable to predicate.	0.5 - 12.0 ug/mL (Predicate: 1.0 - 12.0 ug/mL) - Note: The new device has a slightly wider lower range.
Sample Size (of assay)	Comparable to predicate.	6 µL (Predicate: 40 µL) - Note: The new device uses a significantly smaller sample size.
Measurement Technology	Immunoassay method.	PETINIA (Turbidimetric rate at 340 nm and 700 nm) (Predicate: EMIT®, Colorimetric rate at 340 nm) - Note: Different but both immunoassay principles.

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

Test Set Sample Size: 120 (for the split-sample comparative performance).
Data Provenance: Not explicitly stated (e.g., country of origin). The data is from a "split-sample comparative performance" study, which by its nature is a prospective comparison of the new device against the predicate on the same samples.

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

Not applicable. This study did not involve establishing a ground truth through expert consensus. Instead, it compared the new device's measurements directly against those of a legally marketed predicate device. The predicate device's measurements served as the comparative standard.

4. Adjudication Method for the Test Set

Not applicable. As the study is a direct comparative measurement against a predicate, there was no need for adjudication by experts.

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 a study for an in vitro diagnostic (IVD) device (a laboratory test for measuring a substance in a sample), not an imaging or AI-assisted diagnostic device involving human readers or interpretation of medical cases.

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

Yes, in essence. The "Dimension® Lidocaine (LIDO) Flex® reagent cartridge method" is an automated in vitro diagnostic assay. Its performance (accuracy, precision, linearity, etc.) is evaluated inherently as a standalone system. The study performed here is a "standalone" comparison of its analytical performance against another standalone analytical system (the predicate device). There is no "human-in-the-loop" component for interpretation in the context of this device.

7. The Type of Ground Truth Used

The "ground truth" for the test set was the measurements obtained from the predicate device, the Dade Behring aca® LIDO analytical test pack method (K833379). This is a "comparison to a legally marketed device" or "predicate device comparison" type of ground truth for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This medical device (an in vitro diagnostic assay and calibrator) does not utilize machine learning or AI models, and therefore does not have a "training set" in that context. The development of the reagent cartridge and its parameters would have involved various optimization studies, but these are not referred to as a "training set" in the sense of AI/ML.

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

Not applicable, as there is no "training set" as defined for AI/ML models.

Summary

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

FEB 2 0 2004

Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Name:	Richard M. VaughtDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	December 5, 2003
Name of Product(s):	Dimension® Lidocaine (LIDO) Flex® reagent cartridge method andDimension® Drug Calibrator II (DC49D)
FDA Classification Name(s):	Lidocaine test system (Class II) and Calibrator (Class II)
Predicate Device(s):	Dade Behring aca® LIDO analytical test pack [K833379] andDade Behring Dimension® Drug Calibrator II (DC49C) [K032574]

Device Description(s):

Method

The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® LIDO Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbition immunoassay (PETINIA) which uses a latex particle-lidocaine conjugate and monoclonal lidocaine specific antibody. Lidocaine present in the sample competes with lidocaine on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of lidocaine in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.

Calibrator

The Dade Behring Drug Calibrator 11 (DC49D) is liquid, bovine serum base product, packaged as ten vials to a carton, with two vials at each of five levels; each vial contains 5.0 mL. This same product, the Dade Behring Drug Calibrator II (DC49C), was previously cleared (K032574) for calibration of its associated methods on the Dimension® clinical chemistry system. The product remains unchanged except for the additional value assignment for the Lidocaine constituent. The DC49D product contains the following value assigned analytes and one unassigned constituent (Quinidine):

Image /page/0/Picture/10 description: The image shows the number 000005. The numbers are in a bold, sans-serif font. The numbers are black and the background is white. The image is slightly blurry.

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

1 -Lidocaine (LIDO) 2- Acetaminophen (ACTM) 3- Carbamazepine (CRBM) 4- Digitoxin (DGTX) 5- Gentamicin (GENT)

6- N-acetylprocainamide (NAPA) 7- Procainamide (PROC) 8- Tobramycin (TOBR) 9- Valproic acid (VALP) 10- Vancomycin (VANC)

Unassigned: Quinidinc

Intended Use:

Method

The Dimension® Lidocaine (LIDO) Flex® reagent cartridge method is used for the quantitative determination of lidocaine in serum or plasma. Measurements may be used in the diagnosis and treatment of lidocaine overdose, and in therapeutic drug monitoring.

Calibrator

The Dimension® Drug Calibrator II (DC49D) is intended for calibration of the above ten (10) value-assigned methods on the Dade Behring Dimension® clinical chemistry system.

Comparison to Predicate Device(s):

Method

A summary of the features of the Dade Behring Dimension® LIDO Flex® reagent cartridge method and the predicate device, the Dade Behring aca® LIDO analytical test pack (K833379) is provided in the following chart:

Feature	Dimension® LIDO Flex® cartridge	aca® LIDO analytical test pack
Intended Use	in vitro diagnostice use	in vitro diagnostic use
Assay Range	0.5 - 12.0 ug/mL	1.0 - 12.0 ug/mL
Sample size	6 uL	40 uL
Measurement	PETINIAturbidimetric rate340 nm and 700nm	EMIT®1colorimetric rate340 nm

Registered trademark of Syva Company, Dade Behring Inc.

Split-sample comparative performance was evaluated between the Dade Behring Dimension® LIDO Flex® method and the predicate aca® LIDO analytical test pack method. The results are summarized below:

ComparativeMethod	Slope	Intercept(ug/mL)	CorrelationCoefficient	n
Dade Behringaca® LIDO test pack	0.985	-0.037	0.99	120

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

Calibrator

The Dimension Drug Calibrator II (DC49D) is identical in design and content to the currently cleared Drug Calibrator II (DC49C) product with the exception of the labeling change to identify the Lidocaine values at each level. There are no other differences in the design or manufacture of the Drug Calibrator II product.

Comments on Substantial Equivalence:

Both Dade Behring products, the Dimension® Lidocaine (LIDO) Flex® reagent cartridge method and the aca® LIDO analytical test pack method are homogenous intended for the quantitative determination of lidocaine in serum or plasma. Split-sample comparative data demonstrates good agreement (correlation) between the methods. The calibrator products are identical except the value assignments to the lidocaine constituent.

Conclusion:

The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method and the predicate Dade Behring aca® LIDO analytical test pack method (K833379) are substantially equivalent based on their intended use and comparison performance characteristics as described above. The Dade Behring Dimension® Drug Calibrator II products (DC49C and DC49D) are identical in composition and design and are both utilized for calibration of methods on the Dimension® system.

Richard M. Vaught Regulatory Affairs and Compliance Manager December 5, 2003

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 0 2004

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community Bldg. 500 - M. S. 514; P.O. Box 6101 Newark, DE 19714

K033809 Re:

Trade/Device Name: Dimension® Lidocaine (LIDO) Flex® reagent cartridge method, and Dimension® Drug Calibrator II (DC49D) Regulation Number: 21 CFR 862.3555 Regulation Name: Lidocaine test system Regulatory Class: Class II Product Code: KLR; DKB Dated: December 5, 2003 Received: December 8, 2003

Dear Mr. Vaught:

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 for abound in the 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). and Oosmetter For (110) war the device, subject to the general controls provisions of the Act. The r ou may, disterer, mains 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 (sec above) into either class II (Special Controls) or class III (PMA), it If your de rice is enach additional controls. Existing major regulations affecting your device can may oe subject to sacer adon accept 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 i that FDA has made a determination that your device complies with other requirements of the Act that I Dr Areal statutes and regulations administered by other Federal agencies. You must or any I vith 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).

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

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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications For Use Statement

Device(s) Name(s):

Dimension® Lidocaine (LIDO) Flex® reagent cartridge method, and Dimension® Drug Calibrator II (DC49D)

Indications for Use:

Richard M. Vaught Regulatory Affairs and Compliance Manager

February 2, 2004

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson

Division Sign-Off

ice of In Vitro Diagnostic Device aluation and Safety

510(k) K033809

Prescription Use
(Per 21 CFR 801.109)

Over-the-counter Use_

(Optional format 1-2-96)

revised page 000004

Regulation Number and Section

§ 862.3555 Lidocaine test system.

(a)
Identification. A lidocaine test system is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.(b)
Classification. Class II.