(80 days)
For in vitro diagnostic use only. VITROS Chemistry Products AAT Reagent is used to quantitatively measure α₁-antitrypsin concentration in human serum. The measurement of α₁-antitrypsin in serum aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT).
For in vitro diagnostic use only. VITROS Chemistry Products AAT Performance Verifiers are assayed controls used to monitor performance of VITROS AAT Reagents on VITROS 5,1 FS Chemistry Systems.
The VITROS Chemistry Products AAT Reagent is used in conjunction with the VITROS Chemistry Products Calibrator Kit 99 and VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) on VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT) in human serum.
The VITROS AAT Reagent is a dual chambered package containing ready-to-use liquid reagents. Samples, calibrators and controls are automatically diluted in saline from VITROS FS Diluent Pack 2 and mixed with Reagent 1 containing a polymer. Addition of antisera specific for human α₁-antitrypsin (Reagent 2) produces an immunochemical reaction yielding antigen/antibody complexes. The light scattering properties of the antigen/antibody complexes increase solution turbidity proportional to α₁-antitrypsin concentration in the sample. The turbidity is measured spectrophotometrically at 340 nm. Once a calibration has been performed for each reagent lot, the a1-antitrypsin concentration in each unknown sample can be determined using the stored calibration curve and the measured absorbance obtained in the assay of the sample.
The VITROS Chemistry Products Calibrator Kit 99 are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT).
The VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) is a common reagent that is used by multiple assays on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 is prepared from processed water to which inorganic salt has been added. Diluent 2 is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added.
The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) premarket notification (K031924).
The VITROS Chemistry Products AAT Performance Verifiers I, II and III are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added. These are assayed controls used to monitor performance of VITROS AAT Reagent on VITROS 5,1 FS Chemistry Systems.
Here's an analysis of the acceptance criteria and supporting studies for the VITROS Chemistry Products AAT Reagent, Calibrator Kit 99, and Performance Verifiers, based on the provided text.
Note: This document describes an in vitro diagnostic device, not an AI/ML-driven medical device for image analysis as might be typical for some of these questions. Therefore, some of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set) are not directly applicable or are not explicitly detailed in the provided text for this type of device. I will address the relevant sections and note when information is not present or applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable acceptance criteria with specific performance targets (like sensitivity/specificity for clinical decisions). Instead, performance is shown through correlation and comparison to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Correlation with Predicate Device (AAT Reagent) | Passing & Bablock linear regression: y = 0.93x + 2.06 mg/dL (where y = VITROS AAT assay, x = IMMAGE AAT assay) |
| Specificity Validation | Bench testing performed (details not quantified) |
| Expected Values Validation | Bench testing performed (details not quantified) |
| Limit of Detection Validation | Bench testing performed (details not quantified) |
| Dilution Validation | Bench testing performed (details not quantified) |
| Specimen Matrix Validation | Bench testing performed (details not quantified) |
| Reportable Range (AAT Reagent) | 30.00 - 450.00 mg/dL (VITROS AAT assay) vs. 10 - 3,600 mg/dL (IMMAGE AAT assay). Note: This is a difference, not necessarily an "acceptance criterion" per se, but a characteristic acknowledged. |
| Intended Use Equivalence (AAT Reagent) | Quantitative measurement of α₁-antitrypsin in human samples to aid in diagnosis of α₁-antitrypsin deficiency. |
| Intended Use Equivalence (Performance Verifiers) | Assayed controls used to monitor performance on VITROS Chemistry Systems. |
| Assay Method Equivalence (AAT Reagent) | Immunoturbidimetric (New) vs. Nephelometric (Predicate). Note: This is a difference, but overall equivalence was demonstrated. |
| Calibrator Levels & Format Equivalence (AAT Reagent) | Five levels, Liquid (New) vs. Single level, Lyophilized (Predicate). Note: Differences acknowledged, but overall equivalence demonstrated. |
| Analyte Equivalence (Performance Verifiers) | α₁-Antitrypsin (AAT) (New) vs. Several including C3, C4, IgA, IgG, IgM, transferrin (Predicate). Note: Difference acknowledged, but specific for AAT. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions that equivalence was demonstrated "using a commercially available assay along with patient samples." However, the exact number of patient samples used in the correlation studies (test set) is not specified in the provided text.
- Data Provenance: The data provenance is stated as "patient samples," but the country of origin or whether it was retrospective or prospective data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this in vitro diagnostic device. The "ground truth" for an AAT assay would typically be established by comparing its results to a well-established reference method or a predicate device on patient samples, based on quantitative measurements rather than expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
This question is not applicable for this in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation where experts disagree), not for quantitative chemical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret cases, and performance with/without AI assistance is evaluated. This document describes a chemical assay, not an imaging device with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone performance study was done. The entire submission describes the performance of the VITROS AAT assay system (reagent, calibrator, verifiers, and instrument) as a standalone device to measure α₁-antitrypsin concentration in human serum. Its performance is compared to a predicate device and validated through various bench tests (specificity, expected values, limit of detection, dilution, specimen matrix). The "algorithm" in this context is the immunoturbidimetric chemical reaction and the spectrophotometric measurement by the VITROS 5,1 FS Chemistry System.
7. The Type of Ground Truth Used
The ground truth for validating the VITROS Chemistry Products AAT assay was established through comparison to a predicate device (IMMAGE® Immunochemistry Systems AAT assay) using patient samples, and through bench testing for various analytical performance characteristics (specificity, limit of detection, etc.). For a quantitative chemical assay, the "ground truth" is typically a known, well-characterized value or the result obtained from a recognized reference method.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an AI/ML algorithm. For an IVD assay like this, product development involves a series of experiments and optimizations to establish reagent formulations, calibration curves, and analytical procedures. The phrase "training set" doesn't directly apply in the same way it would for AI model development. The development data used to optimize the assay would implicitly serve this purpose, but its sample size is not specified.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" ground truth as applied to AI/ML isn't directly applicable here. The development of the assay would involve establishing the expected concentrations of AAT in various samples, using reference methods or characterized materials, to ensure the assay accurately measures the analyte. The specific methodology or exact sample sizes for this developmental phase are not provided in the summary.
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DEC 2 3 2005
Image /page/0/Picture/1 description: The image shows the logo for Ortho-Clinical Diagnostics. The logo consists of a stylized caduceus symbol on the left, followed by the text "Ortho-Clinical Diagnostics" in a sans-serif font. A thin line underlines the text, emphasizing the company name.
Johnion company a Johnson
100 Indigo Creek Drive
Rochester, New York 14626-510!
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: K052819
| 1. Submitter name, address, contact | Ortho-Clinical Diagnostics, Inc.100 Indigo Creek DriveRochester, New York 14626-5101(585) 453-4253Contact Person: Darlene Phillips |
|---|---|
| 2. Preparation Date | October 3, 2005 |
| 3. Device name | Trade or Proprietary Names:VITROS Chemistry Products AAT ReagentVITROS Chemistry Products Calibrator Kit 99VITROS Chemistry Products AAT Performance Verifiers I, II & IIICommon Names:Alpha-1-antitrypsin (AAT) assay and controlsClassification Names:Alpha-1-antitrypsin immunological test system (866.5130) Class IICalibrator (862.1150) Class IIQuality Control material (assayed and unassayed) (862.1660) Class I(general controls). Since these devices (AAT Performance Verifiers I, II & III) are assayed controls, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act. |
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| 4. PredicateDevices | The VITROS Chemistry Products AAT assay is substantiallyequivalent to the IMMAGE® Immunochemistry Systems AATassay. |
|---|---|
| The VITROS Chemistry Products AAT Performance Verifiers aresubstantially equivalent to the previously cleared VITROSChemistry Products Protein Performance Verifiers. | |
| 5. Devicedescription | The VITROS Chemistry Products AAT Reagent is used inconjunction with the VITROS Chemistry Products Calibrator Kit 99and VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline)on VITROS 5,1 FS Chemistry Systems for the quantitativemeasurement of α₁-antitrypsin (AAT) in human serum. |
| The VITROS AAT Reagent is a dual chambered package containingready-to-use liquid reagents. Samples, calibrators and controls areautomatically diluted in saline from VITROS FS Diluent Pack 2 andmixed with Reagent 1 containing a polymer. Addition of antiseraspecific for human α₁-antitrypsin (Reagent 2) produces animmunochemical reaction yielding antigen/antibody complexes. Thelight scattering properties of the antigen/antibody complexesincrease solution turbidity proportional to α₁-antitrypsinconcentration in the sample. The turbidity is measuredspectrophotometrically at 340 nm. Once a calibration has beenperformed for each reagent lot, the a1-antitrypsin concentration ineach unknown sample can be determined using the stored calibrationcurve and the measured absorbance obtained in the assay of thesample. | |
| The VITROS Chemistry Products Calibrator Kit 99 are preparedfrom processed human serum to which inorganic salts, buffers, andpreservatives have been added. These standards are used tocalibrate VITROS 5,1 FS Chemistry Systems for the quantitativemeasurement of α₁-antitrypsin (AAT). | |
| The VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline)is a common reagent that is used by multiple assays on the VITROS5,1 FS System. This is a dual chambered package containing twoready-to-use liquid diluents. Diluent 1 is prepared from processedwater to which inorganic salt has been added. Diluent 2 is preparedfrom processed water to which bovine serum albumin, inorganicsalts and preservatives have been added. | |
| The VITROS 5,1 FS Chemistry System is a clinical chemistryinstrument that provides automated use of the VITROS ChemistryProducts MicroTip® and MicroSlides® range of products. TheVITROS 5,1 FS System was cleared for market by 510(k) premarketnotification (K031924). | |
| 6. Deviceintendeduses | VITROS Chemistry Products AAT Reagent: For in vitro diagnosticuse only. VITROS Chemistry Products AAT Reagent is used toquantitatively measure α₁-antitrypsin concentration in human serum. |
| VITROS Chemistry Products Calibrator Kit 99: For in vitrodiagnostic use only. VITROS Chemistry Products Calibrator Kit 99 isused to calibrate VITROS 5,1 FS Chemistry Systems for thequantitative measurement of α1-antitrypsin (AAT). | |
| VITROS Chemistry Products AAT Performance Verifiers I, II &III: For in vitro diagnostic use only. VITROS Chemistry ProductsAAT Performance Verifiers are assayed controls used to monitorperformance of VITROS AAT Reagents on VITROS 5,1 FS ChemistrySystems. | |
| 7. Comparisontopredicatedevices: | The VITROS Chemistry Products AAT Reagent and VITROS ChemistryProducts Calibrator Kit 99 are substantially equivalent to the IMMAGE®Immunochemistry Systems AAT Reagent (K964766) and Calibrator 2(K973932) (predicate devices) which were cleared by the FDA for IVDuse.Passing & Bablock linear regression analysis demonstrated the following |
| relationship:$y = 0.93x + 2.06 mg/dL$where y = results obtained using the VITROS Chemistry Products AATassay and x = results obtained with the commercially available systemIMMAGE® Immunochemistry Systems AAT assay in conventional units. | |
| The VITROS Chemistry Products AAT Performance Verifiers I, II & IIIare substantially equivalent to the VITROS Chemistry Products ProteinPerformance Verifiers I, II & III (K042477) (predicate device) which wascleared by the FDA for IVD use. |
The VITROS Chemistry Products AAT Performance Verifiers I, II and III are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added. These are assayed controls used to monitor performance of VITROS AAT Reagent on VITROS 5,1 FS Chemistry Systems.
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In addition to correlation studies, bench testing was performed to nr addition to corrention station, specificity, expected values, limit of detection, dilution and specimen matrix of the VITROS AAT assay.
- Similarities and differences of the assays performed using the VITROS AAT Table 1 assay and the IMMAGE® AAT assay.
| Device Similarities | ||
|---|---|---|
| Indications for Use | For in vitro diagnostic use. Quantitative measurement of α₁-antitrypsin in human samples. The measurement of α₁-antitrypsin in serum aids in the diagnosis of α₁-antitrypsin deficiency. | |
| Antibody source | Ovine (Goat) | |
| Instrumentation | Clinical chemistry analyzer | |
| Calibrator matrix | Human serum | |
| Differences | ||
| Device Characteristic | VITROS AAT assay(New device) | IMMAGE AAT assay(Predicate device) |
| Sample Type | Serum | Serum |
| Reportable Range | 30.00 - 450.00 mg/dL | 10 - 3,600 mg/dL |
| Calibrator levels | Five levels | Single level |
| Calibrator format | Liquid | Lyophilized |
| Method | Immunoturbidimetric | Nephelometric |
- Similarities and differences of the device characteristics between the VITROS Table 2 AAT Performance Verifiers I, II & III with the predicate device VITROS Chemistry Products Protein Performance Verifiers I, II & III.
| Device Similarities | ||
|---|---|---|
| Indications for Use | For in vitro diagnostic use. Assayed controls used to monitor the performance on VITROS Chemistry Systems. | |
| Matrix | The performance verifiers are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added. | |
| Format | Liquid | |
| Number of levels | Three | |
| Differences | ||
| DeviceCharacteristic | VITROS AAT PerformanceVerifiers(New Device) | VITROS Protein PerformanceVerifiers(Predicate Device) |
| AnalytesReported | α₁-Antitrypsin (AAT) | Several including complement C3 (C3), complement C4 (C4), IgA, IgG, IgM and transferrin. |
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- Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products AAT Reagent, VITROS Chemistry Products Calibrator Kit 99, and the VITROS Chemistry Products AAT Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.
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VITROS Chemistry Products AAT assay and controls
:
:
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Ortho-Clinical Diagnostics, Inc. c/o Ms. Darlene J. Phillips Regulatory Affairs Associate 100 Indigo Creek Dr. Rochester, NY 14626-5101
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 3 2005
Re: K052819
Trade/Device Name: VITROS Chemistry Products AAT Reagent VITROS Chemistry Products Calibrator Kit 99 VITROS Chemistry Products AAT Performance Verifiers I, II and III Regulation Number: 21 CFR 866.5130 Regulation Name: Alpha-1 antitrypsin immunological test system Regulatory Class: Class II Product Code: DEM, JIX, JJX Dated: October 3, 2005 Received: October 25, 2005
Dear Ms. Phillips:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 rotty programially equivalent (for the indications for referenced above and nave actemination arketed predicate devices marketed in interstate commerce use stated in the encrosure/ to regally than of the Medical Device Amendments, or to devices that provision in way 26, 1770, the enadinee with the provisions of the Federal Food, Drug, and Cosmetic Ilave bech reclassified in accordance wof a premarket approval application (PMA). You may, Act (Act) that do the require apprect to the general controls provisions of the Act. The general therefore, market the device, salgos to annual registration, listing of devices, good controls provisions of the of the prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc ao or) into Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. 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 loase be advised mark i 27 r o sessan that your device complies with other requirements of the Act or that FDA nas made a decemination that yostered by other Federal agencies. You must comply with ally Federal statutes and regaration abut not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, moractice requirements as set forth in the quality fabeling (21 CFR Part 800); and if applicable, the electronic product radiation systems (QB) 10gars (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin mailing of substantial equivalence of your device to legally
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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), please
rs and the may on any and 2011 - Alama descreeness the requirely of If you desire specific advice for your dones at (240) 276-0131. Also, please note the regulation of contact the Uffice of Compliance at (240) 210 other Pat 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obta "Misbranding by reference to premailsoriise under the Act from the Division of Small
general information on your responsibilities under the Act from the (800) 6 general information on your responsibilities and reveal and the toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(301)445-0577 of arts microstaaaaaaaaa.html
Sincerely yours,
Robert L. Becker, Jr., M.D., PhD
Director Division of Immunology and Hematology Devices Division of Initialisms.
Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
ﮯ ﮨﮯ ۔ ۔۔۔
Page 1 of 1
| 510(k) Number (if known): | K052819 |
|---|---|
| Device Name: | VITROS Chemistry Products AAT ReagentVITROS Chemistry Products Calibrator Kit 99VITROS Chemistry Products AAT Performance Verifiers I, II, and III |
| Indications for Use: | For in vitro diagnostic use only. VITROS Chemistry Products AAT Reagent is used to quantitatively measure α₁-antitrypsin concentration in human serum. The measurement of α₁-antitrypsin in serum aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema.For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT).For in vitro diagnostic use only. VITROS Chemistry Products AAT Performance Verifiers are assayed controls used to monitor performance of VITROS AAT Reagents on VITROS 5,1 FS Chemistry Systems. |
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
| 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)
Mana Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K052819
§ 866.5130
Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).