(79 days)
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.
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.
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 is composed of processed water and 0.9% w/v sodium chloride (Saline).
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.
The provided text is a 510(k) summary for in-vitro diagnostic devices (calibrators and performance verifiers). It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a medical imaging device or AI algorithm might. Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this document.
However, I will extract the information that is present and indicate where the requested information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the format typical for a clinical study comparing an AI device's output to a ground truth. Instead, the "acceptance criterion" is effectively substantial equivalence to existing predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (VITROS Chemistry Products Calibrator Kit 16, VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products RF Performance Verifiers I and II) | The submission argues that the new devices (VITROS Chemistry Products Calibrator Kit 28, VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products ASO/RF Performance Verifiers I and II) are substantially equivalent to the predicate devices. The FDA concurred with this determination, as indicated by the clearance letter (K052645). |
The tables provided (Tables 1, 2, and 3) detail similarities and differences in device characteristics (intended use, fluid matrix, analyte levels, analyte, traceability, format) between the new devices and their respective predicates. These comparisons serve as the basis for the declaration of substantial equivalence. For example:
- VITROS Calibrator Kit 28 (New) vs. VITROS Calibrator Kit 16 (Predicate):
- Intended Use: Differs (ASO vs. RF calibration)
- Fluid Matrix: Same (aqueous solution)
- Analyte Levels: Differs (one level vs. five levels)
- Analyte: Differs (ASO vs. RF)
- Traceability: Differs (NIBSC 97/6621 vs. NIBSC 64/22)
- Format: Same
- VITROS FS Calibrator Kit 1 (New) vs. VITROS FS Calibrator Kit 1 (Predicate):
- Intended Use: Similar (calibration of VITROS 5,1 FS systems, but new device supports additional calibrator kits)
- Fluid Matrix: Same
- Analyte Levels: Same
- Analyte: ASO (for new device's context) vs. RF (for predicate's context) - Note: The table lists ASO for the new device and RF for the predicate, which is slightly confusing as FS Calibrator 1 is a general diluent/calibrator component. The text clarifies its use with various kits.
- Traceability: Differs (NIBSC 97/6621 vs. NIBSC 64/22)
- Format: Same
- VITROS ASO/RF Performance Verifiers I and II (New) vs. VITROS RF Performance Verifiers I and II (Predicate):
- Intended Use: Similar (monitoring performance, but new device includes ASO)
- Fluid Matrix: Same
- Analyte Levels: Same
- Analyte: Differs (ASO and RF vs. RF)
- Format: Same
The "reported device performance" is not a set of quantitative metrics from an independent study, but rather the claim that these devices perform equivalently to the predicate devices for their intended use, based on their design and components.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an algorithm or imaging study. The evaluation performed is a comparison of device characteristics for substantial equivalence. There is no mention of a sample size of patient data or clinical samples tested for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission (IVD calibrators/controls). There is no "ground truth" established by experts in the context of reviewing images or clinical data. The "ground truth" for the calibrators and verifiers themselves would be established through their manufacturing and quality control processes to ensure their stated values and stability.
4. Adjudication Method for the Test Set
Not applicable. No "adjudication method" is described as there is no test set in the sense of clinical cases needing expert review.
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 an IVD device submission for calibrators and controls, not an AI or imaging diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The devices are reagents/calibrators used with an automated chemistry system (VITROS 5,1 FS Chemistry Systems). They are not standalone algorithms or software-only devices.
7. The Type of Ground Truth Used (Expert Concensus, Pathology, Outcomes Data, etc.)
For IVD calibrators and controls, the "ground truth" for their values and performance characteristics is established through analytical validation processes, often traceable to international reference standards (e.g., NIBSC standards mentioned: NIBSC 97/6621 for ASO, NIBSC 64/22 for RF). This involves manufacturing controls, stability studies, and performance testing to ensure they accurately calibrate and monitor the assay. It is not an expert consensus on clinical findings, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as these are physical diagnostic reagents, not machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
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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
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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
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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.
| DeviceCharacteristic | VITROS Calibrator Kit 28New device #1 | VITROS Calibrator Kit 16Predicate device #1 |
|---|---|---|
| Intended Use | For in vitro diagnostic use only.VITROS Chemistry ProductsCalibrator Kit 28 is used inconjunction with VITROS ChemistryProducts FS Calibrator 1 to calibrateVITROS 5,1 FS Chemistry Systemsfor the quantitative measurement ofantistreptolysin O (ASO). | For in vitro diagnostic use only.VITROS Chemistry Products CalibratorKit 16 is used in conjunction withVITROS Chemistry Products FSCalibrator 1 to calibrate VITROS 5,1 FSChemistry Systems for the quantitativemeasurement 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
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- 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.
| DeviceCharacteristic | VITROS FS Calibrator Kit 1New device #2 | VITROS FS Calibrator Kit 1Predicate device #2 |
|---|---|---|
| Intended Use | For in vitro diagnostic use onlyVITROS Chemistry Products FSCalibrator 1 is used in conjunctionwith VITROS Calibrator Kits 16, 17,18, 19 and 28 to calibrate VITROS5,1 FS Chemistry Systems. | For in vitro diagnostic use onlyVITROS Chemistry Products FSCalibrator 1 is used in conjunction withVITROS Calibrator Kits 16, 17, 18 and19 to calibrate VITROS 5,1 FSChemistry 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.
| DeviceCharacteristic | VITROS ASO/RF PerformanceVerifiers I and IINew device #3 | VITROS RF Performance Verifiers Iand IIPredicate device #3 |
|---|---|---|
| Intended Use | For in vitro diagnostic use only. VITROSChemistry Products ASO/RF PerformanceVerifiers are assayed controls used tomonitor the performance of VITROS ASOand RF Reagents on VITROS 5,1 FSChemistry Systems. | For in vitro diagnostic use only. VITROSChemistry Products RF PerformanceVerifiers are assayed controls used tomonitor performance of VITROS RFReagent on VITROS 5,1 FS ChemistrySystems. |
| Fluid Matrix | Same | A base matrix of processed human serumto which purified human proteins, bovineserum albumin and preservative havebeen 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
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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.
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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).
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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 (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
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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
§ 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.