(80 days)
No
The device description details a standard spectrophotometric immunoassay method for measuring α₁-antitrypsin concentration. The analysis relies on measuring turbidity and using a stored calibration curve, which are traditional laboratory techniques and do not indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is described as "For in vitro diagnostic use only" and measures markers to aid in diagnosis, not to treat or directly affect the body.
Yes
The intent of the device, as stated in "Intended Use / Indications for Use", is "For in vitro diagnostic use only." and "The measurement of α₁-antitrypsin in serum aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema." This directly indicates the device's diagnostic purpose.
No
The device description clearly outlines physical reagents (liquid reagents, calibrators, diluents) and their use on a physical instrument (VITROS 5,1 FS Chemistry System). This is not a software-only device.
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" for the AAT Reagent, Calibrator Kit 99, and AAT Performance Verifiers.
- Purpose: The device is used to measure α₁-antitrypsin concentration in human serum, which is a biological sample taken from the body.
- Diagnostic Aid: The measurement of α₁-antitrypsin is stated to "aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema." This clearly indicates a diagnostic purpose.
- Method: The description details an immunochemical reaction and spectrophotometric measurement, which are common in vitro diagnostic techniques.
- Components: The system includes reagents, calibrators, and controls, all of which are typical components of an in vitro diagnostic system.
- System Context: The device is used on a "clinical chemistry instrument" (VITROS 5,1 FS Chemistry System), which is designed for performing in vitro diagnostic tests.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DEM, JIX, JJX
Device Description
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 α₁-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.
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)
Correlation studies and bench testing were performed. Bench testing included precision, linearity, specificity, expected values, limit of detection, dilution and specimen matrix analysis of the VITROS AAT assay. 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 AAT assay and x = results obtained with the commercially available system IMMAGE® Immunochemistry Systems AAT assay in conventional units.
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.
IMMAGE® Immunochemistry Systems AAT Reagent (K964766), Calibrator 2 (K973932)
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.
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
§ 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).
0
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 Drive
Rochester, New York 14626-5101
(585) 453-4253
Contact Person: Darlene Phillips |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Preparation Date | October 3, 2005 |
| 3. Device name | Trade or Proprietary Names:
VITROS Chemistry Products AAT Reagent
VITROS Chemistry Products Calibrator Kit 99
VITROS Chemistry Products AAT Performance Verifiers I, II & III
Common Names:
Alpha-1-antitrypsin (AAT) assay and controls
Classification Names:
Alpha-1-antitrypsin immunological test system (866.5130) Class II
Calibrator (862.1150) Class II
Quality 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. |
Continued on next page
1
| 4. Predicate
Devices | The VITROS Chemistry Products AAT assay is substantially
equivalent to the IMMAGE® Immunochemistry Systems AAT
assay. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The VITROS Chemistry Products AAT Performance Verifiers are
substantially equivalent to the previously cleared VITROS
Chemistry Products Protein Performance Verifiers. |
| 5. Device
description | 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). |
| 6. Device
intended
uses | VITROS Chemistry Products AAT Reagent: For in vitro diagnostic
use only. VITROS Chemistry Products AAT Reagent is used to
quantitatively measure α₁-antitrypsin concentration in human serum. |
| | VITROS Chemistry Products Calibrator Kit 99: 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). |
| | VITROS Chemistry Products AAT Performance Verifiers I, II &
III: 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. |
| 7. Comparison
to
predicate
devices: | The VITROS Chemistry Products AAT Reagent and VITROS Chemistry
Products 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 IVD
use.
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 AAT
assay and x = results obtained with the commercially available system
IMMAGE® Immunochemistry Systems AAT assay in conventional units. |
| | The VITROS Chemistry Products AAT Performance Verifiers I, II & III
are substantially equivalent to the VITROS Chemistry Products Protein
Performance Verifiers I, II & III (K042477) (predicate device) which was
cleared 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.
Continued on next page
2
Continued on next page
:
3
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 | ||
| Device | ||
| Characteristic | VITROS AAT Performance | |
| Verifiers | ||
| (New Device) | VITROS Protein Performance | |
| Verifiers | ||
| (Predicate Device) | ||
| Analytes | ||
| Reported | α₁-Antitrypsin (AAT) | Several including complement C3 (C3), complement C4 (C4), IgA, IgG, IgM and transferrin. |
Continued on next page
4
-
- 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.
5
VITROS Chemistry Products AAT assay and controls
:
:
6
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
7
Page 2
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
8
Indications for Use
ﮯ ﮨﮯ ۔ ۔۔۔
Page 1 of 1
| 510(k) Number (if known): | K052819 |
|---|---|
| Device Name: | VITROS Chemistry Products AAT Reagent |
| VITROS Chemistry Products Calibrator Kit 99 | |
| VITROS 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