Drug Calibrator II is intended to be used to calibrate the Acetaminophen (ACTM), Carbamazepine (CRBM), Gentamicin (GENT), Tobramycin (TOBR), Valproic Acid (VALP), and Vancomycin (VANC) methods for the Dimension® clinical chemistry system.

Drug Calibrator II is an in vitro diagnostic product intended for use in an in vitro test system to establish points of reference that are used in the determination of values in the measurement of human substances.

Device Description

Drug Calibrator II (K962817) is being modified to add valproic acid as an additional constituent on the product labeling. Drug Calibrator II is a liguid product. Level 1 is bovine albumin. Levels 2 through 5 contain acetaminophen, carbamazepine, gentamicin, tobramycin, valproic acid and vancomycin in a bovine albumin base. The kit consists of ten vials; two at each of five levels, containing 5 mL each.

AI/ML Overview

The provided document is a 510(k) summary for a Drug Calibrator II device. It describes a modification to an existing calibrator to include valproic acid. The document explicitly states that the modified device is substantially equivalent to the predicate device and does not contain any information regarding performance studies, acceptance criteria, sample sizes, or ground truth establishment.

Therefore, many of the requested details cannot be extracted from this document, as it focuses on the administrative process of claiming substantial equivalence rather than a detailed scientific study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be answered from the provided text. The document states that the modified Drug Calibrator II is "substantially equivalent" to the predicate device. It does not provide any specific acceptance criteria or reported device performance metrics for either the original or modified device. The comparison table lists "Intended Use," "Analyte," "Matrix," "Form," "Volume," and "Levels" as attributes, but not performance-based acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be answered from the provided text. No test set, studies, or data provenance information is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be answered from the provided text. As no test set or ground truth establishment is described, neither the number nor the qualifications of experts are mentioned.

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

Cannot be answered from the provided text. No adjudication method is described because no test set or study requiring adjudication is present.

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

Cannot be answered from the provided text. This is not an AI-powered device, nor is any MRMC study or human reader performance mentioned. The device is a calibrator for a clinical chemistry system.

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

Cannot be answered from the provided text. This is not an algorithm-based device. It is a physical calibrator product.

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

Cannot be answered from the provided text. No ground truth is described. For a calibrator, "ground truth" would typically refer to the certified concentrations of the analytes within the calibrator solutions, established through rigorous chemical analysis, but this information is not included in the 510(k) summary.

8. The sample size for the training set

Cannot be answered from the provided text. No training set is applicable or mentioned for this type of device.

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

Cannot be answered from the provided text. As there is no training set, there is no discussion of how its ground truth might be established.

Summary of what the document does provide:

The document focuses on demonstrating substantial equivalence of a modified medical device to a legally marketed predicate device. The only change described is the addition of valproic acid as a constituent to an existing drug calibrator product.

Device Name: Drug Calibrator II (Modified)
Intended Use: To calibrate Acetaminophen (ACTM), Carbamazepine (CRBM), Gentamicin (GENT), Tobramycin (TOBR), Valproic Acid (VALP), and Vancomycin (VANC) methods for the Dimension® clinical chemistry system.
Predicate Device: Drug Calibrator II (K962817)
Comparison: The modified device is identical to the predicate except for the inclusion of valproic acid in its labeling and composition. Both are liquid products in a bovine albumin matrix, 5.0 mL per vial, and come in 5 levels.
Conclusion: The modified Drug Calibrator II is substantially equivalent to the currently marketed Drug Calibrator II.

Summary

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1982871

DADE BEHRING

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

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:	Rebecca S. AyashDade Behring Inc.Building 500, Mailbox 514P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	8/13/98
Device Name:	Drug Calibrator II
Classification Name:	Calibrator, Drug Mixture
Predicate Device:	Drug Calibrator II (K962817)

Device Description: Drug Calibrator II (K962817) is being modified to add valproic acid as an additional constituent on the product labeling. Drug Calibrator II is a liguid product. Level 1 is bovine albumin. Levels 2 through 5 contain acetaminophen, carbamazepine, gentamicin, tobramycin, valproic acid and vancomycin in a bovine albumin base. The kit consists of ten vials; two at each of five levels, containing 5 mL each.

Intended Use: Drug Calibrator II is intended to be used to calibrate the Acetaminophen (ACTM), Carbamazepine (CRBM), Gentamicin (GENT), Tobramycin (TOBR), Valproic Acid (VALP), and Vancomycin (VANC) methods for the Dimension® clinical chemistry system.

Comparison to Predicate Device:

	Drug Calibrator II	Drug Calibrator II (Modified)
Intended Use	Calibrator	Calibrator
Analyte	Acetaminophen, carbamazepine,gentamicin, tobramycin,vancomycin	Acetaminophen, carbamazepine,gentamicin, tobramycin, valproic acid,vancomycin
Matrix	Bovine albumin	Bovine albumin
Form	Liquid	Liquid
Volume	5.0 mL per vial	5.0 mL per vial
Levels	5 levels	5 levels

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Comments on Substantial Equivalence: Drug Calibrator II (modified) is the same product as the product currently marketed (K962817) with the only difference being revision of the labeling to add the constituent valproic acid. Both products are intended to be used as calibrators for drug assays.

Conclusion: Drug Calibrator II (modified) is substantially equivalent to the currently marketed Drug Calibrator II based on the comparison summarized above.

Rebecca S. Cayton

Rebecca S. Avash Regulatory Affairs and Compliance Manager Date: 8/13/98

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 3 1998

Rebecca S. Ayash Regulatory Affairs and Compliance Manger Dade Behring, Inc. Glasgow Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

Re : K982871 Drug Calibrator II Regulatory Class: II Product Code: DKB Dated: August 13, 1998 Received: August 14, 1998

Dear Ms. Ayash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕਿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications Statement

Device Name: Drug Calibrator II

Indications for Use: Drug Calibrator II is an in vitro diagnostic product intended for use in an in vitro test system to establish points of reference that are used in the determination of values in the measurement of human substances. ---

Rebecca Slenysh

Rebecca S. Ayash Regulatory Affairs and . Compliance Manager Date: 8/13/98

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number

Division Sign-Off Office of Device Evaluation

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.