For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Reagent is used to quantitatively measure apolipoprotein A1 (ApoA1) concentration in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 21 is used to calibrate VITROS 5.1 FS Chemistry Systems for the quantitative measurement of apolipoprotein A 1 (ApoA1). For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Performance Verifier I is an assayed controls used to monitor the performance of ApoA1 Reagent on VITROS 5,1 FS Chemistry Systems.

For in vitro diagnostic use only. VITROS Chemistry Products ApoB Reagent is used to quantitatively measure apolipoprotein B (ApoB) concentration in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 22 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein B (ApoB). For in vitro diagnostic use only. VITROS Chemistry Products ApoB Performance Verifier I is an assayed controls used to monitor the performance of ApoB Reagent on VITROS 5,1 FS Chemistry Systems.

Device Description

The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.

The system is comprised of four main elements:

The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products ApoA1 Reagent and VITROS Chemistry Products Calibrator Kit 21, VITROS Chemistry Products ApoB Reagent and VITROS Chemistry Products Calibrator Kit 22, VITROS Chemistry Products ApoA1 Performance Verifier I and VITROS Chemistry Products ApoB Performance Verifier I ), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS ApoA1 and ApoB assays.
The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 1).

The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VITROS Chemistry Products ApoA1 and ApoB assays, Calibrator Kits, and Performance Verifiers, based on the provided text:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than defining explicit numerical acceptance criteria for novel performance claims. The key "acceptance criterion" for substantial equivalence is the demonstration of similar performance characteristics and intended use compared to the legally marketed predicate devices.

The study presented here is a correlation study comparing the new devices to the predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Device Characteristic	Acceptance Criteria (Implied by Predicate Comparison)	VITROS ApoA1 Assay Performance	VITROS ApoB Assay Performance
Correlation	Correlation coefficient (r) with predicate device should be high, indicating agreement.	r = 0.987 (vs. Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent assay)	r = 0.985 (vs. Dade Behring N Antisera to Human Apolipoprotein B Reagent assay)
Linear Regression Formula (Slope & Intercept)	Linear relationship should be close to identity (slope ~1, intercept ~0) to predicate device.	VITROS ApoA1 = 0.98 X - 13.04 (mg/dL)	VITROS ApoB = 1.00 X - 3.88 (mg/dL)
Intended Use	Must be consistent with the predicate device.	For quantitative measurement of ApoA1 in human serum and plasma. Used in diagnosis and treatment of lipid disorders, atherosclerosis, and various liver/renal diseases.	For quantitative measurement of ApoB in human serum and plasma. Used in diagnosis and treatment of lipid disorders, atherosclerosis, and various liver/renal diseases.
Method	Immunoturbidimetric, matching predicate.	Immunoturbidimetric	Immunoturbidimetric
Reactive Ingredients	Similar reactive ingredients.	Goat antisera to human apolipoprotein A1	Goat antisera to human apolipoprotein B
Instrumentation	Specified for VITROS 5,1 FS Chemistry System.	VITROS 5,1 FS Chemistry System	VITROS 5,1 FS Chemistry System
Reportable Range	Similar range to predicate, suitable for clinical use.	ApoA1: 30.00-240.00 mg/dL	ApoB: 35.00-300.00 mg/dL
Sample Type	Human Serum (and plasma for new devices).	Human Serum and Plasma	Human Serum and Plasma

Note: The document also states that "studies were performed to determine the precision, specificity, linearity, antigen excess, lower limit of detection, and expected values of the VITROS ApoA1 and ApoB assays," with summaries in the Instructions for Use. However, the specific acceptance criteria and results for these additional studies are not provided in this summary document.

Study Details

Sample Size used for the test set and the data provenance:
- The document states: "Equivalence to predicate(s) was demonstrated using commercially available reagents along with patient samples."
- Specific sample size for the test set is NOT provided.
- Data Provenance: The origin (e.g., country) of the patient samples is NOT specified. The study appears to be retrospective in the sense that existing patient samples were used to perform the correlation with a legally marketed predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a predicate comparison study for an in vitro diagnostic (IVD) assay, not a study involving human expert interpretation of images or clinical data.
- No "experts" in the sense of clinicians or radiologists were used to establish ground truth. The "ground truth" for the test set is established by the results obtained from the predicate device's assay, which is itself a legally marketed and presumably validated quantitative test.
Adjudication method for the test set:
- Not applicable. This study does not involve human interpretation or adjudication as it's a quantitative measurement device comparison.
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. This is an IVD device, not an AI-assisted diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. The study assessed the performance of the VITROS ApoA1 and ApoB assays as standalone quantitative measurement devices by comparing their results directly to those of the predicate assays. There is no human-in-the-loop component for the measurement itself, as it is an automated chemistry system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is established by the results obtained from the legally marketed predicate devices (Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent assay and Dade Behring N Antisera to Human Apolipoprotein B Reagent assay) when measuring the same patient samples. This is a common approach for demonstrating substantial equivalence for new IVD assays.
The sample size for the training set:
- Not applicable. This document describes a predicate comparison study for an IVD kit, which does not involve a "training set" in the context of machine learning or AI. The development of the assay itself would have involved internal validation and method optimization, but that is distinct from a "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" in the context of this regulatory submission for an IVD assay.

Summary

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Chapter 1 - Summary Information

510(k) Summary

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.

The assigned 510(k) number is: 长042521

Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, Rochester, New York 14626-5101 address, (585) 453-4041 contact Contact Person: Marlene A. Hanna
Date 510(k) prepared: September 15, 2004 2. Preparation Date
Trade or Proprietary Name(s): 3. Device VITROS Chemistry Products ApoA1 Reagent name VITROS Chemistry Products Calibrator Kit 21 VITROS Chemistry Products ApoA1 Performance Verifier I

VITROS Chemistry Products ApoB Reagent VITROS Chemistry Products Calibrator Kit 22 VITROS Chemistry Products ApoB Performance Verifier I

Common Name(s): Apolipoprotein A1 (ApoAl) assay Apolipoprotein B (ApoB) assay

Classification Name(s): Lipoprotein test systems (862.1475): Class: I (general controls). Since these devices (ApoA1 and ApoB reagent) are used in assessing risk of artherosclerosis, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.

Calibrator (862.1150): Calibrator Kits 21 and 22: Class II.

Quality Control material (assayed and unassayed) (862.1660): Class I (general controls). Since these devices (ApoA1 and ApoB Performance Verifiers I) are assayed controls, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.

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The VITROS Chemistry Products ApoA1 assay is substantially equivalent to 4. Predicate a. the Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent and N Devices Apoliprotein Standard Serum.
- b. The VITROS Chemistry Products ApoB assay is substantially equivalent to the Dade Behring N Antisera to Human Apolipoprotein B Reagent and N Apoliprotein Standard Serum.
- The VITROS Chemistry Products ApoA1 and ApoB Performance Verifiers I ﻦ are substantially equivalent to the Dade Behring Apolipoprotein Control Serum CHD.
1. Device The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human description specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.

The system is comprised of four main elements:

1. The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
1. The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products ApoA1 Reagent and VITROS Chemistry Products Calibrator Kit 21, VITROS Chemistry Products ApoB Reagent and VITROS Chemistry Products Calibrator Kit 22, VITROS Chemistry Products ApoA1 Performance Verifier I and VITROS Chemistry Products ApoB Performance Verifier I ), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS ApoA1 and ApoB assays.
1. The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
1. Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 1).

The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

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a. VITROS Chemistry Products ApoA1 Reagent: For in vitro diagnostic use only. 6. Device(s) VITROS Chemistry Products ApoA1 Reagent is used to quantitatively measure intended apolipoprotein A1 (ApoA1) concentration in human serum and plasma. use
b. VITROS Chemistry Products ApoB Reagent: For in vitro diagnostic use only. VITROS Chemistry Products ApoB Reagent is used to quantitatively measure apolipoprotein B (ApoB) concentration in human serum and plasma.

c. VITROS Chemistry Products Calibrator Kit 21: For in vitro diagnostic use only, VITROS Chemistry Products Calibrator Kit 21 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein A1 (ApoA1).

d. VITROS Chemistry Products Calibrator Kit 22: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 22 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein B (ApoB).

e. VITROS Chemistry Products ApoA1 Performance Verifier I: For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Performance Verifier I is an assayed control used to monitor the performance of ApoA1 Reagent on VITROS 5,1 FS Chemistry Systems.

f. VITROS Chemistry Products ApoB Performance Verifier I: For in vitro diagnostic use only. VITROS Chemistry Products ApoB Performance Verifier I is an assaved control used to monitor the performance of ApoB Reagent on VITROS 5,1 FS Chemistry Systems.

7. Comparison to predicate

device(s): Apo A1 Reagent Pack and Calibrators

The VITROS Chemistry Products ApoA1 Reagent and VITROS Chemistry Products Calibrator Kit 21 are substantially equivalent to the Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent (K860894) and N Apoliprotein Standard Serum (K041870) (predicate devices) which were cleared by the FDA for IVD use.

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The relationship between the VITROS ApoA1 and the predicate device, determined by least squares linear regression, is:

VITROS ApoA1 = 0.98 X - 13.04 (mg/dL),

with a correlation coefficient of 0.987,

where X is Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent assay.

Apo B Reagent Pack and Calibrators

The VITROS Chemistry Products ApoB Reagent and VITROS Chemistry Products Calibrator Kit 22 are substantially equivalent to the Dade Behring N Antisera to Human Apolipoprotein B Reagent (K860894) and N Apoliprotein Standard Serum (K041870) (predicate devices) which were cleared by the FDA for IVD use.

The relationship between the VITROS ApoB and the predicate device, determined by least squares linear regression, is:

VITROS ApoB = 1.00 X - 3.88 (mg/dL),

with a correlation coefficient of 0.985, where X is Dade Behring N Antisera to Human Apolipoprotein B Reagent assay.

In addition to the above mentioned correlation study, studies were performed to determine the precision, specificity, linearity, antigen excess, lower limit of detection, and expected values of the VITROS ApoA1 and ApoB assays, (refer to the VITROS ApoA1 and ApoB Reagent's Instructions for Use for summaries of the results of these studies).

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Table 1 lists the characteristics of the assays performed using the VITROS ApoA1 andApoB assays and the Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent and the Dade Behring N Antisera to Human Apolipoprotein B Reagent assays.

Table 1 lists the characteristics of the VITROS ApoA1 and ApoB (new devices) Table 1 and the DADE Apo A-1 and Apo B (predicate device).

DeviceCharacteristic	VITROS ApoA1 and ApoB(New device)	DADE Apo A-1 and ApoB(Predicate device)
Intended Use	For in vitro diagnostic useonly. VITROS ChemistryProducts ApoA1 and ApoBReagents are used toquantitatively measureapolipoprotein A1 (ApoA1)and apolipoprotein B (ApoB)concentration in human serumand plasma.	In vitro diagnostic reagents forthe quantitative determinationof apolipoprotein A-1 (Apo A-1) and apolipoprotein B (ApoB) in human serum.
Method	Immunoturbidimetric	Immunoturbidimetric
Reportable Range:ApoA1:ApoB:	30.00-240.00 mg/dL35.00-300.00 mg/dL	19-600 mg/dL25-400 mg/dL
Sample Type	Human Serum	Human Serum
Reactive IngredientsApoA1:ApoB:	Goat antisera to humanapolipoprotein A1Goat antisera to humanapolipoprotein B	Rabbit antisera to HumanApoA-1Rabbit antisera to HumanApoB
Instrumentation	VITROS 5,1 FS ChemistrySystem	DADE BN ProSpec

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Performance Verifiers

The VITROS Chemistry Products ApoA1 and ApoB Performance Verifiers I are substantially equivalent to the Dade Behring Apolipoprotein Control Serum CHD (predicate device) which was cleared by the FDA (K993310) for IVD use.

Table 2 lists the similarities and differences of the device characteristics between the VITROS ApoA1 and ApoB Performance Verifiers I with the predicate device, the Dade Behring Apolipoprotein Control Serum CHD.

Table 2

DeviceCharacteristic	VITROS ApoA1 and ApoB(New Device)	DADE ApoA1 and ApoB(Predicate Device)
Intended Use	For in vitro diagnostic useonly. VITROS ChemistryProducts ApoA1 and ApoBPerformance Verifiers I areassayed controls used tomonitor the performance ofApoA1 and ApoB Reagent onVITROS 5,1 FS ChemistrySystems.	Apolipoprotein ControlSerum CHD is used as anassayed control foraccuracy and precision inthe quantitativeimmunochemicaldetermination ofapolipoprotein A-1 and Bwith the BehringNephelometer Systems.
Matrix	Prepared from processedhuman serum to whichinorganic salts, buffers,organic compounds, bovineserum albumin, andpreservatives have beenadded.	Stabilized reagent fromhuman serum.
Form	Liquid	Lyophilized
Volume	0.5 mL per vial	0.5 mL per vial

Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS ApoAl and ApoB assays and the VITROS Chemistry Products ApoA1 and ApoB Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices.

Equivalence to predicate(s) was demonstrated using commercially available reagents along with patient samples.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Marlene A Hanna, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101

NOV 1 8 2004

Re: K042521

Trade/Device Name: VITROS Chemistry Products ApoA1 Reagent VITROS Chemistry Products Calibrator Kit 21 VITROS Chemistry Products ApoA1 Performance Verifier I VITROS Chemistry Products ApoB Reagent VITROS Chemistry Products Calibrator Kit 22 VITROS Chemistry Products ApoB Performance Verifier I Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, MSJ, JJX Dated: September 15, 2004 Received: September 16, 2004

Dear Ms. Hanna:

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).

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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,

Cornelia B. Parks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use for the ApoA1 assay

510(k) Number (if known):

VITROS Chemistry Products ApoA1 Reagent Device Name(s): VITROS Chemistry Products Calibrator Kit 21 VITROS Chemistry Products ApoA1 Performance Verifier I Indications for Use: For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Reagent is used to quantitatively measure apolipoprotein A1 (ApoA1) concentration in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 21 is used to calibrate VITROS 5.1 FS Chemistry Systems for the quantitative measurement of apolipoprotein A 1 (ApoA1). For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Performance Verifier I is an assayed controls used to monitor the performance of ApoA1 Reagent on VITROS 5,1 FS Chemistry Systems. ﺳﺎ

Prescription Use _ (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Carol Benn
Division Sign-Off

Office of in Vitro Diagnostic Devina Evaluation and Safety

510(k) K042521

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Indications for Use for the ApoB assay

510(k) Number (if known):

Device Name(s):	VITROS Chemistry Products ApoB Reagent
	VITROS Chemistry Products Calibrator Kit 22
	VITROS Chemistry Products ApoB Performance Verifier I
Indications for Use:	For in vitro diagnostic use only. VITROS Chemistry Products ApoB Reagent is used to quantitatively measure apolipoprotein B (ApoB) concentration in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
	For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 22 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein B (ApoB).
	For in vitro diagnostic use only. VITROS Chemistry Products ApoB Performance Verifier I is an assayed controls used to monitor the performance of ApoB Reagent on VITROS 5,1 FS Chemistry Systems.

Prescription Use
(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2 - 1

Carol Benner
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

EiO(k) K04252

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.