Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes calibrators and controls for a chemistry system, which are standard components in in vitro diagnostics and do not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the text.

Therapeutic

No

The intended use statements clearly state that these devices are "For in vitro diagnostic use only" and are used for calibration and monitoring performance of diagnostic systems, not for treating any condition.

Diagnostic

No

The document describes calibrators and performance verifiers used to calibrate and monitor the performance of diagnostic systems, not a diagnostic device itself.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like aqueous solutions, processed human serum, protein, inorganic salt, preservative, processed water, sodium chloride, and lyophilized assayed controls. These are all tangible, non-software elements.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." multiple times.
Function: The device (specifically the Calibrator Kit 28 and FS Calibrator 1) is used to calibrate a chemistry system for the quantitative measurement of antistreptolysin O (ASO). This measurement is performed on biological samples (implied by the use of human serum in the calibrator and controls), which is a core characteristic of in vitro diagnostics.
Context: The device is used in conjunction with a reagent (VITROS Chemistry Products ASO Reagent) and a chemistry system (VITROS 5,1 FS Chemistry Systems) to perform a diagnostic test.

The description of the performance verifiers also reinforces the IVD nature, as they are used to monitor the performance of the diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 28 is used in coniunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin O (ASO).

For in vitro diagnostic use only.

VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems.

For in vitro diagnostic use only. VITROS Chemistry Products ASO/RF Performance Verifiers are assayed controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS Chemistry Systems.

Product codes (comma separated list FDA assigned to the subject device)

GTQ

Device Description

The quantitative measurement of antistreptolysin O is performed using the VITROS Chemistry Products ASO Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 28 and VITROS Chemistry Products FS Calibrator 1 on VITROS 5,1 FS Chemistry Systems. The FDA has classified Streptococcus spp. exoenzyme reagents (Sec. 866.3720) in Class I (general controls), therefore, the VITROS Chemistry Products ASO Reagent is exempt from premarket notification procedures in 21 CFR Part 807 Subpart E.

VITROS Chemistry Products Calibrator Kit 28

VITROS Chemistry Products Calibrator Kit 28 is an aqueous solution containing processed human serum, protein, inorganic salt, and preservative.

VITROS Chemistry Products FS Calibrator 1

VITROS Chemistry Products FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline).

VITROS Chemistry Products ASO/RF Performance Verifier I and II

VITROS Chemistry Products ASO/RF Performance Verifiers contain two levels of lyophilized assayed controls for use in monitoring performance of VITROS ASO and RF Reagents on VITROS 5,1 FS Chemistry Systems.

These controls are prepared from processed human serum to which purified human proteins, bovine serum albumin and preservative have been added. These controls are reconstituted with VITROS Chemistry Products FS Reconstitution Diluent that contains processed water.

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)

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K041863

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.3720

Streptococcus spp. exoenzyme reagents.(a)
Identification. Streptococcus spp. exoenzyme reagents are devices used to identify antibodies toStreptococcus spp. exoenzyme in serum. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Summary

0

DEC 1 4 2005

5.0 510(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: 1052045

5.1 Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-3143 Fax: (585) 453-3368 Contact Person: Michael M. Byrne

5.2 Date of Preparation:

9/23/05

Device Proprietary Names: 5.3

Trade Names	VITROS Chemistry Products Calibrator Kit 28
	VITROS Chemistry Products FS Calibrator 1
	VITROS Chemistry Products ASO/RF Performance Verifier I and II
Common Name	Antistreptolysin O calibrators and controls

5.4 Classification Names

Classification Name: Calibrator (21 CFR 862.1150): Class II

Classification Name: Quality Control material (assayed and unassayed) (21 CFR 862.1660): Class I: Reserved

ર્સ્ડ Predicate devices

The VITROS Chemistry Products Calibrator Kit 28, VITROS Chemistry Products FS Calibrator 1 and VITROS Chemistry Products ASO/RF Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 16, VITROS Chemistry Products FS Calibrator 1 and VITROS Chemistry Products RF Performance Verifiers I and II, respectively. The predicate devices were cleared by the FDA (K041863) for IVD use.

Ortho-Clinical Diagnostics, Inc. VITROS Calibrator Kit 28, VITROS FS Calibrator 1, and VITROS ASORF Performance Verificas Page 6 of 32

1

5.6 Device description

The quantitative measurement of antistreptolysin O is performed using the VITROS Chemistry Products ASO Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 28 and VITROS Chemistry Products FS Calibrator 1 on VITROS 5,1 FS Chemistry Systems. The FDA has classified Streptococcus spp. exoenzyme reagents (Sec. 866.3720) in Class I (general controls), therefore, the VITROS Chemistry Products ASO Reagent is exempt from premarket notification procedures in 21 CFR Part 807 Subpart E.

VITROS Chemistry Products Calibrator Kit 28

VITROS Chemistry Products Calibrator Kit 28 is an aqueous solution containing processed human serum, protein, inorganic salt, and preservative.

VITROS Chemistry Products FS Calibrator 1

VITROS Chemistry Products FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline).

VITROS Chemistry Products ASO/RF Performance Verifier I and II

VITROS Chemistry Products ASO/RF Performance Verifiers contain two levels of lyophilized assayed controls for use in monitoring performance of VITROS ASO and RF Reagents on VITROS 5,1 FS Chemistry Systems.

These controls are prepared from processed human serum to which purified human proteins, bovine serum albumin and preservative have been added. These controls are reconstituted with VITROS Chemistry Products FS Reconstitution Diluent that contains processed water.

5.7 Device intended use

VITROS Chemistry Products Calibrator Kit 28

For in vitro diagnostic use only.

VITROS Chemistry Products Calibrator Kit 28 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin O (ASO).

VITROS Chemistry Products FS Calibrator 1

For in vitro diagnostic use only.

VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems. continued on next page

2

VITROS Chemistry Products ASO/RF Performance Verifier I and II

For in vitro diagnostic use only

VITROS Chemistry Products ASO/RF Performance Verifiers are assayed quality controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS Chemistry Systems.

5.8 Comparison to predicate device

The VITROS Chemistry Products Calibrator Kit 28, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products ASO/RF Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 16, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products RF Performance Verifiers I and II, respectively. These predicate devices were cleared by the FDA (K041863) for IVD use.

Tables 1, 2, and 3 provide similarities and differences between the new devices and predicate devices.

Table 1 Table 1 lists the similarities and differences of the device characteristics between new device, VITROS Chemistry Products Calibrator Kit 28 and predicate device, VITROS Chemistry Products Calibrator Kit 16.

| Device
Characteristic | VITROS Calibrator Kit 28
New device #1 | VITROS Calibrator Kit 16
Predicate device #1 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.
VITROS Chemistry Products
Calibrator Kit 28 is used in
conjunction with VITROS Chemistry
Products FS Calibrator 1 to calibrate
VITROS 5,1 FS Chemistry Systems
for the quantitative measurement of
antistreptolysin O (ASO). | For in vitro diagnostic use only.
VITROS Chemistry Products Calibrator
Kit 16 is used in conjunction with
VITROS Chemistry Products FS
Calibrator 1 to calibrate VITROS 5,1 FS
Chemistry Systems for the quantitative
measurement of rheumatoid factor (RF). |
| Fluid Matrix | Same | An aqueous solution |
| Analyte Levels | One level | Five levels |
| Analyte | Antistreptolysin O (ASO) | Rheumatoid factor (RF) |
| Traceability | NIBSC 97/6621 | NIBSC 64/22 |
| Format | Same | Liquid ready to use |

Continued on next page

3

Table 2 Table 2 lists the similarities and differences of the device characteristics between new device, VITROS Chemistry Products FS Calibrator Kit 1 and predicate device, VITROS Chemistry Products FS Calibrator Kit 1.

| Device
Characteristic | VITROS FS Calibrator Kit 1
New device #2 | VITROS FS Calibrator Kit 1
Predicate device #2 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only
VITROS Chemistry Products FS
Calibrator 1 is used in conjunction
with VITROS Calibrator Kits 16, 17,
18, 19 and 28 to calibrate VITROS
5,1 FS Chemistry Systems. | For in vitro diagnostic use only
VITROS Chemistry Products FS
Calibrator 1 is used in conjunction with
VITROS Calibrator Kits 16, 17, 18 and
19 to calibrate VITROS 5,1 FS
Chemistry Systems. |
| Fluid Matrix | Same | Saline and processed water |
| Analyte Levels | Same | One level |
| Analyte | Antistreptolysin O (ASO) | Rheumatoid factor (RF) |
| Traceability | NIBSC 97/6621 | NIBSC 64/22 |
| Format | Same | Liquid ready to use |

Table 3 Table 3 lists the similarities and differences of the device characteristics between new device, VITROS ASO/RF Performance Verifiers and predicate device, VITROS RF Performance Verifiers.

| Device
Characteristic | VITROS ASO/RF Performance
Verifiers I and II
New device #3 | VITROS RF Performance Verifiers I
and II
Predicate device #3 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only. VITROS
Chemistry Products ASO/RF Performance
Verifiers are assayed controls used to
monitor the performance of VITROS ASO
and RF Reagents on VITROS 5,1 FS
Chemistry Systems. | For in vitro diagnostic use only. VITROS
Chemistry Products RF Performance
Verifiers are assayed controls used to
monitor performance of VITROS RF
Reagent on VITROS 5,1 FS Chemistry
Systems. |
| Fluid Matrix | Same | A base matrix of processed human serum
to which purified human proteins, bovine
serum albumin and preservative have
been added. |
| Analyte Levels | Same | Low and High |
| Analyte | Antistreptolysin O and Rheumatoid factor | Rheumatoid factor |
| Format | Same | Lyophilized |

ર. 9 Conclusions

The information presented in this premarket notification provide a reasonable assurance that the VITROS Chemistry Products Calibrator Kit 28 when used in conjunction with VITROS Chemistry Systems FS Calibrator 1 and the VITROS Chemistry Products ASO/RF Performance Verifiers I and II are safe and effective for the stated intended uses.

Continued on next page

Ortho-Clinical Diagnostics, Inc. VITROS Calibrator Kit 28, VITROS FS Calibrator 1, and VITROS ASO/RF Performance Verifiers Page 9 of 32

4

Ortho-Clinical Diagnostics, Inc. believes that the VITROS Chemistry Products Calibrator Kit 28, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products ASO/RF Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 16, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products RF Performance Verifiers I and II, respectively. These predicate devices were cleared by the FDA (K041863) for IVD use.

5

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

DEC 1 4 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael M. Byrne Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: K052645

Trade/Device Name: VITROS Chemistry Products Calibrator Kit 28 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products ASO/RF Performance Verifier I and II Regulation Number: 21 CFR 862.1150

Regulation Name: Calibrator Regulatory Class: Class II Product Code: GTQ Dated: November 21, 2005 Received: November 22, 2005

Dear Mr. Byrne:

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 yours,

Sally a story

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

7

Indications for Use

510(k) Number (if known): K052645

VITROS Chemistry Products Calibrator Kit 28 Device Name: VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products ASO/RF Performance Verifiers I and

Indications For Use: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 28 is used in coniunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin O (ASO).

For in vitro diagnostic use only.

VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems.

For in vitro diagnostic use only. VITROS Chemistry Products ASO/RF Performance Verifiers are assayed controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS Chemistry Systems.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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)

Ney Catan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

510(k) K052645