(203 days)
k 060585
Not Found
No
The device description details a standard immunoenzymometric assay and data analysis based on a standard curve, with no mention of AI or ML techniques.
No
This device is for in vitro diagnostic use, meaning it measures ACTH levels in a sample to aid in diagnosis, not to treat a condition.
Yes
The document states that the device is "designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome." This explicitly indicates its use in diagnosis.
No
The device description clearly outlines a physical immunoassay kit involving reagents, magnetic beads, and a fluorogenic substrate, which is performed on a Tosoh AIA System Analyzer. This indicates a hardware-dependent in vitro diagnostic device, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY..." and "ST AIA-PACK ACTH Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY..." and "ST AIA-PACK ACTH Control Set is designed for IN VITRO DIAGNOSTIC USE ONLY...".
- Purpose: The device is intended for the quantitative measurement of a substance (ACTH) in a human sample (EDTA plasma) to aid in the diagnosis and treatment of specific medical conditions (disorders of the adrenal glands). This is a core function of an in vitro diagnostic device.
- Methodology: The device uses an immunoassay performed on a human sample outside of the body, which is characteristic of an in vitro diagnostic test.
- Intended User/Care Setting: The "IN VITRO DIAGNOSTIC USE ONLY" statement further reinforces its classification as an IVD.
N/A
Intended Use / Indications for Use
ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are useful in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
ST AIA-PACK ACTH Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK ACTH assay on Tosoh AIA Systems Analyzers.
The AIA-PACK ACTH Control Set is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK ACTH Assay.
Product codes (comma separated list FDA assigned to the subject device)
CKG, JIT, JJX
Device Description
The ST AIA-PACK ACTH is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK ACTH test cups. ACTH present in the test sample is bound with anti-ACTH goat polyclonal antibody immobilized on magnetic beads and enzyme-labeled anti-ACTH goat polyclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled anti-ACTH goat polyclonal antibody and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The enzyme alkaline phosphatase causes oxidation of 4MUP to 4MU. 4MU is excited at 365 nm and comes to ground state at 448 nm releasing florescent energy. The amount of florescent energy is measured by the detector.
The amount of enzyme-labeled anti-ACTH goat polyclonal antibody that binds to the beads is directly proportional to the ACTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
The following products are required to use the ST AIA-PACK ACTH: ST AIA-PACK ACTH Calibrator Set (P/N 025221), ST AIA-PACK ACTH Sample Diluting Solution (P/N 025321), AIA-PACK ACTH Control Set (P/N 025521).
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)
Precision Study:
Study type: Precision study, developed with reference to CLSI protocol EPS-A2.
Sample size: Three levels of unaltered EDTA plasma specimens.
Key results: Precision was assessed by assaying 2 replicates in a single run, 2 times a day for 20 non-consecutive days, totaling 40 runs and 80 determinants.
Within Run Precision (Mean (pg/mL), Pooled SD, CV%):
EDTA Plasma-A: 37.8, 1.2, 3.1 (Reagent Set #1); 44.3, 1.2, 2.8 (Reagent Set #2); 40.9, 0.89, 2.2 (Reagent Set #3).
EDTA Plasma-B: 223.7, 4.8, 2.1 (Reagent Set #1); 244.6, 5.1, 2.1 (Reagent Set #2); 230.0, 5.3, 2.3 (Reagent Set #3).
EDTA Plasma-C: 709.2, 10.9, 1.5 (Reagent Set #1); 740.4, 15.6, 2.1 (Reagent Set #2); 719.1, 15.5, 2.2 (Reagent Set #3).
Total Precision (Mean (pg/mL), Pooled SD, CV%):
EDTA Plasma-A: 37.8, 1.2, 3.3 (Reagent Set #1); 44.3, 1.9, 4.2 (Reagent Set #2); 40.9, 1.03, 2.5 (Reagent Set #3).
EDTA Plasma-B: 223.7, 5.7, 2.5 (Reagent Set #1); 244.6, 9.3, 3.8 (Reagent Set #2); 230.0, 6.4, 2.8 (Reagent Set #3).
EDTA Plasma-C: 709.2, 15.6, 2.2 (Reagent Set #1); 740.4, 25.1, 3.4 (Reagent Set #2); 719.1, 15.9, 2.2 (Reagent Set #3).
Linearity Study:
Study type: Linearity study, developed with reference to CLSI protocol EP6-A.
Key results: The repeatability CV% met the criterion of 5,000pg/mL) or ACTH 22-39 (>100,000 pg/mL). These fragments may negatively affect the ACTH assay. It is likely that these fragments bind to either the antibodies on beads or the enzyme-labeled antibodies. Therefore, if these fragments were contained excessively in the test sample, lower values may be reported.
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.
k 060585
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
§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.
(a)
Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.(b)
Classification. Class II.
0
K 111/335
DEC - 1 2011
510(k) Summary
ST AIA-PACK ACTH
Date:
Submitter:
Contact Person: ﻣﺴ ﺎ
Device Name:
Classification:
Device Name:
Classification
Device Name:
Classification
Predicate Device:
August 16, 2011
Tosoh Bioscience, Inc 3600 Gantz Road Grove City, OH 43123
Judith K. Ogden Director, New Business & Technical Development 6000 Shoreline Ct., Ste. 101 South San Francisco, CA 94080 Phone: 650-636-8112 Fax: 650-636-8113 Email: Judy.Ogden@tosoh.com
ST AIA-PACK ACTH
Class II CKG Clinical Chemistry 21 CFR 862.1025
ST AIA-PACK ACTH Calibrator Set
Class II JIT Clinical Chemistry 21 CFR 862.1150
AIA-PACK ACTH Control Set
Class I אר Clinical Chemistry 21 CFR 862.1660
k 060585 Roche Diagnostics Elecsys ACTH Immunoassay Elecsys ACTH CalSet
1
510(k) Summary
ST AIA-PACK ACTH
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Device Description:
The ST AIA-PACK ACTH is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK ACTH test cups. ACTH present in the test sample is bound with anti-ACTH goat polyclonal antibody immobilized on magnetic beads and enzyme-labeled anti-ACTH goat polyclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled anti-ACTH goat polyclonal antibody and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The enzyme alkaline phosphatase causes oxidation of 4MUP to 4MU. 4MU is excited at 365 nm and comes to ground state at 448 nm releasing florescent energy. The amount of florescent energy is measured by the detector.
The amount of enzyme-labeled anti-ACTH goat polyclonal antibody that binds to the beads is directly proportional to the ACTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
| The following products are required to use the ST AIA-PACK ACTH | P/N 025221: |
|---|---|
| ST AIA-PACK ACTH Calibrator Set | P/N 025321 |
| ST AIA-PACK ACTH Sample Diluting Solution | P/N 025521 |
| AIA-PACK ACTH Control Set | P/N 025421 |
Device Intended Use:
ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are useful in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
ST AIA-PACK ACTH Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK ACTH assay on Tosoh AIA Systems Analyzers.
The AIA-PACK ACTH Control Set is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK ACTH Assay.
ST AIA-PACK ACTH
3 of 9
2
Substantial Equivalence:
Comparison between the Tosoh ST AIA-PACK ACTH and the Roche Diagnostics Elecsys ACTH Immunoassay
Similarities:
| Item | Device | Predicate |
|---|---|---|
| ST AIA-PACK ACTH | Elecsys ACTH | |
| Intended Use | ST AIA-PACK ACTH is | |
| designed for IN VITRO | ||
| DIAGNOSTIC USE ONLY | ||
| for the quantitative | ||
| measurement of | ||
| Adrenocorticotropic hormone | ||
| (ACTH) in human EDTA | ||
| plasma on Tosoh AIA System | ||
| Analyzers. | Immunoassay for the in vitro | |
| quantitative determination of | ||
| adrenocorticotropic hormone | ||
| (ACTH) in human EDTA | ||
| plasma. The | ||
| electrochemiluminescence | ||
| immunoassay "ECLIA" is | ||
| intended for use on the Roche | ||
| Elecsys 1010/2010 and | ||
| MODULAR ANALYTICS | ||
| E170 (Elecsys module) | ||
| immunoassay analyzers. | ||
| Intended Use Calibrators | ST AIA-PACK ACTH | |
| Calibrator Set is intended for | ||
| IN VITRO DIAGNOSTIC | ||
| USE ONLY for the calibration | ||
| of the ST AIA-PACK ACTH | ||
| assay on Tosoh AIA Systems | ||
| Analyzers. | Elecsys ACTH CalSet is used | |
| for calibrating the quantitative | ||
| Elecsys ACTH assay on the | ||
| Elecsys immunoassay | ||
| analyzers. | ||
| Intended Use Controls | The AIA-PACK ACTH | |
| CONTROL SET is intended | ||
| for IN VITRO DIAGNOSTIC | ||
| USE ONLY for performing | ||
| quality control procedures | ||
| with the ST AIA-PACK | ||
| ACTH Assay. | Elecsys PreciControl ACTH is | |
| used for quality control of the | ||
| Elecsys ACTH immunoassay | ||
| on the Elecsys immunoassay | ||
| analyzers. | ||
| Indications for Use | Plasma ACTH measurements | |
| are useful in the differential | ||
| diagnosis of pituitary | ||
| Cushing's disease (ACTH | ||
| hypersecretion), | ||
| adrenocortical insufficiency | ||
| (Addisons disease), pituitary | ||
| tumors (e.g. Nelson's | ||
| syndrome), hypopituitarism | ||
| with ACTH deficiency and | ||
| ectopic ACTH syndrome. | ACTH measurements are used | |
| in the differential diagnosis | ||
| and treatment of certain | ||
| disorders of the adrenal glands | ||
| such as Cushings syndrome, | ||
| adrenocortical insufficiency, | ||
| and ectopic ACTH syndrome. | ||
| Assay Protocol | Sandwich assay | Sandwich Assay |
| Sample Type | Human EDTA Plasma | Human EDTA Plasma |
| Assay Low | 2.0 pg/mL | 1.0 pg/mL |
| Assay High | 2000 pg/mL | 2000 pg/mL |
| Reference Range | 7.4-64.3 pg/mL | 7.2-63.3 pg/mL |
| Hook Effect | No high dose hook effect up to | |
| 1,000,000 pg/mL | No high dose hook effect up to | |
| 1,000,000 pg/mL | ||
| Control level | Two levels of control: | |
| lyophilized | Two levels of control: | |
| lyophilized |
ST AIA-PACK ACTH
3
Differences:
| Item | Device
ST AIA-PACK ACTH | Predicate
Elecsys ACTH |
|---------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Detection Protocol | Fluorescence | Electrochemiluminescent |
| Calibrator | ST AIA-PACK Calibrator Set
6-Point | ACTH CalSet 2-Point |
| Calibration Interval | 90 days when using same test
cup lot | 3-28 Days depending on
analyzer and storage
conditions |
| Calibration Verification | 6-Point Calibration does not
require calibration verification
material | 3 levels ACTH CalCheck |
| Traceability / Standardization | ACTH (Human, 1-39)
Bachem AG: code. H-1160;
gravimetric preparation | Standardized gravimetrically
with synthetic ACTH
produced by Roche |
| Base Matrix (Control &
Calibrator) | MOPSO Buffer with 5%
Bovine Serum Albumin | Equine serum |
| Reconstituted stability | Up to 7 days when stored at 2
- 8° C when not in use. | Up to 3 hours at 20 - 25° C;
- 20° C one month. |
.
ST AIA-PACK ACTH
4
Precision:
The precision study was developed with reference to the CLSI protocol entitled: Evaluation of Precision Performance of Quantitative Measurement Methods (EPS-A2).
The precision study for the ST AIA-PACK ACTH assay was evaluated utilizing three AIA-2000 analyzers and 3 different lots of reagents. Precision was assessed by assaying three levels of unaltered EDTA plasma specimens. Estimates of total and within-run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days. This equaled to a total of 40 runs and 80 determinants.
| Specimen | Reagent Set # 1 | Reagent Set # 2 | Reagent Set # 3 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | |||||||||
| (pg/mL) | Pooled | ||||||||
| SD | CV | ||||||||
| % | Mean | ||||||||
| (pg/mL) | Pooled | ||||||||
| SD | CV | ||||||||
| % | Mean | ||||||||
| (pg/mL) | Pooled | ||||||||
| SD | CV | ||||||||
| % | |||||||||
| EDTA | |||||||||
| Plasma- | |||||||||
| A | 37.8 | 1.2 | 3.1 | 44.3 | 1.2 | 2.8 | 40.9 | 0.89 | 2.2 |
| EDTA | |||||||||
| Plasma-B | 223.7 | 4.8 | 2.1 | 244.6 | 5.1 | 2.1 | 230.0 | 5.3 | 2.3 |
| EDTA | |||||||||
| Plasma- | |||||||||
| C | 709.2 | 10.9 | 1.5 | 740.4 | 15.6 | 2.1 | 719.1 | 15.5 | 2.2 |
Within Run Precision:
..............................................................................................................................................................................
Total Precision:
| Reagent Set # 1 | Reagent Set # 2 | Reagent Set # 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Specimen | Mean | ||||||||
| (pg/mL) | Pooled | ||||||||
| SD | CV | ||||||||
| % | Mean | ||||||||
| (pg/mL) | Pooled | ||||||||
| SD | CV | ||||||||
| % | Mean | ||||||||
| (pg/mL) | Pooled | ||||||||
| SD | CV | ||||||||
| % | |||||||||
| EDTA | |||||||||
| Plasma- | |||||||||
| A | 37.8 | 1.2 | 3.3 | 44.3 | 1.9 | 4.2 | 40.9 | 1.03 | 2.5 |
| EDTA | |||||||||
| Plasma-B | 223.7 | 5.7 | 2.5 | 244.6 | 9.3 | 3.8 | 230.0 | 6.4 | 2.8 |
| EDTA | |||||||||
| Plasma- | |||||||||
| C | 709.2 | 15.6 | 2.2 | 740.4 | 25.1 | 3.4 | 719.1 | 15.9 | 2.2 |
5
Linearity:
The linearity study was developed with reference to the CLSI protocol entitled: Evaluation of the Linearity of Quantitative Measurement Procedures (EP6-A).
The repeatability CV% met the criterion of 5,000pg/mL) or ACTH 22-39 (>100,000 pg/mL). These fragments may negatively affect the ACTH assay. It is likely that these fragments bind to either the antibodies on beads or the enzyme-labeled antibodies. Therefore, if these fragments were contained excessively in the test sample, lower values may be reported.
Standards:
| Number | FDA
Recognition
Number | Revision
Date | Title |
|--------|------------------------------|------------------|----------------------------------------------------------------------------------------------------------------------|
| C28-A3 | 7-202 | 09/08/2009 | How to Define and Determine Reference Intervals
in the Clinical Laboratory-Third Edition |
| EP5-A2 | 7-110 | 10/31/2005 | Evaluation of Precision Performance of
Quantitative Measurement Methods: Approved
Guideline- Second Edition |
| EP6-A | 7-193 | 03/18/2009 | Evaluation of the Linearity of Quantitative
Measurement Procedures; A Statistical Approach;
Approved Guideline |
| EP9-A2 | 7-92 | 03/08/2004 | Method Comparison and Bias Estimation Using
Patient Samples; Approved Guideline-Second
Edition |
| EP17-A | 7-194 | 03/18/2009 | Protocols for Determination of Limits of Detection
and Limits of Quantitation: Approved Guideline |
Control Value Assignment:
The control value assignments are established on 2 analyzers with 2 lots of ST AIA-PACK ACTH. Both levels of control are assayed in 5 replicates, and the Mean and %CV are calculated. This mean serves as the Grand Mean for the Control Assigned Value Range Validation. The range is established as +/- 20% of the grand mean. The validation acceptance criteria is +/- 10% of the grand mean. The end users are instructed to establish their own range.
Conclusion:
The Tosoh Bioscience, Inc. ST AIA-PACK ACTH is substantially equivalent to the Roche Diagnostics Elecsys ACTH Immunoassay (k)060585 for the in vitro diagnostic use only for the quantitative measurement of ACTH in human EDTA plasma, on Tosoh AIA System Analyzer. Since ACTH is controlled by factors affecting the hypothalamic, pituitary and adrenal glands, the determination of ACTH level is useful in clinical investigation for diseases of these glands.
)
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers.
10903 New Hampshire Avenue Silver Spring, MD 20993
TOSOH BIOSCIENCE, INC c/o Judith Ogden 6000 Shoreline Court Suite 101 South San Francisco, CA 94080
DEC - 1 2011
Re: K111335
Trade Name: ST AIA-PACK ACTH, ST AIA-PACK ACTH Calibrator Set. AIA-PACK ACTH Control Set Regulation Number: 21 CFR 862.1025 Regulation Name: Adrenocorticotropic hormone (ACTH) test system Regulatory Class: Class II Product Codes: CKG, JIT, JJX Dated: November 15, 2011 Received: November 16, 2011
Dear Ms. Ogden:
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. I 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
9
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.html
Sincerely yours,
$\qquad$
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known):
Device Name:
Indication For Use:
Device Name:
Indication For Use:
Device Name:
Indication For Use:
ST AIA-PACK ACTH
ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
ST AIA-PACK ACTH Calibrator Set
ST AIA-PACK ACTH Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers
ST AIA-PACK ACTH Control Set
ST AIA-PACK ACTH Control Set is designed for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers
Prescription Use V (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K-111335