← Product Code [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT) · K070144

# INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS (K070144)

_Beckman Coulter, Inc. · JIT · Feb 1, 2007 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K070144

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT.md)
- **Decision Date:** Feb 1, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1150
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The Access Inhibin A calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric Inhibin A levels in human serum and plasma using the Access Immunoassay Systems. The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay.

## Device Story

Access Inhibin A Calibrators and QC are accessory materials for the Access Immunoassay System; used to calibrate and monitor system performance for quantitative measurement of dimeric Inhibin A in human serum and plasma. Calibrator kit includes seven levels; control kit includes three levels. System utilizes competitive binding immunoenzymatic method. Used in clinical laboratory settings by professional operators. Output provides calibration curve generation and system performance monitoring, enabling accurate quantitative analyte measurement for clinical decision-making.

## Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time) confirmed 28-day open-vial stability at 2–30 °C and 34-day shelf life. Traceability to WHO 91/624 established.

## Technological Characteristics

Liquid solution format; matrix consists of Bovine Serum Albumen; aligned to WHO international standard 91/624. Designed for use with automated competitive binding immunoenzymatic assay systems.

## Regulatory Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Predicate Devices

- Diagnostic Systems Laboratories (DSL) ACTIVE® Inhibin A ELISA Calibrators and Controls ([K002128](/device/K002128.md))

## Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k070144

B. Purpose for Submission:
New Device

C. Measurand:
Calibrator and control materials for Inhibin A

D. Type of Test:
Not applicable.

E. Applicant:
Beckman Coulter Inc.

F. Proprietary and Established Names:
Access Inhibin A Calibrators and QC

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150
21 CFR § 862.1660
2. Classification:
Class II
Class I (reserved)
3. Product code:
JIS, calibrator secondary
JJX, single (specified) analyte controls (assayed and unassayed)
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
The Access Inhibin A calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric Inhibin A levels in human serum and plasma using the Access Immunoassay Systems.

The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay.

2. Indication(s) for use:
See Intended use (above).

3. Special conditions for use statement(s):
For professional use.

3. Special instrument requirements:
Access Inhibin A Calibrators and QC is used to assess the performance of the Access Inhibin A Immunoassay System.

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I. Device Description:

The Access Inhibin A Calibrators and Controls are designed for use with the Access Inhibin A Reagent for the generation of and control of the Inhibin A calibration curve on Beckman Coulter's Access Immunoassay Systems. The Access Inhibin A Calibrator Kit contains 7 x 2.5 mL bottles, one for each of seven calibrator levels. The Access Inhibin A Control Kit contains 3 X 2.5 mL bottles, one for each level of three control levels. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic method for quantitative analyte measurement.

J. Substantial Equivalence Information:

1. Predicate device name(s):
DSL Inhibin A Calibrators and Controls

2. Predicate 510(k) number(s):
k002128

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Analyte | Inhibin A | Inhibin A  |
|  Calibrator Standardization | WHO 91/624 | WHO 91/624  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Matrix | Bovine Serum Albumen | Fetal Bovine Serum  |
|  Calibrator Range | 0-1500 pg/mL | 0-1000 pg/mL  |
|  Quality Control Material | 3 provided | 2 provided  |
|  Assay Type | automated immunoassay | manual ELISA  |

K. Standard/Guidance Document Referenced (if applicable):
None identified.

L. Test Principle:
Not applicable.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not applicable.
b. Linearity/assay reportable range:
Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):

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The inhibin A used in the controls and calibrators are traceable to WHO 91/624. Exact concentrations of the calibrators will be listed in the labeling for each lot. Expected results of the controls will be accompanied by the mean and SD for each lot in the labeling.

Stability characteristics of the Access controls and calibrators were determined using real time studies to determine estimated storage stability at 2 – 30 °C. Open vial stability of the controls was determined and supported a claim of 28 days at 2-30 °C. Open vial stability of the calibrators was determined and supported a claim of 28 days at 2-30 °C. Shelf life stability for both calibrators and controls is claimed to be 34 days based on on-going real time studies. The shelf life listed in the labeling will reflect the time of the real time data tested up to that point.

d. Detection limit:
Not applicable.

e. Analytical specificity:
Not applicable.

f. Assay cut-off:
Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:
Not applicable.

b. Matrix comparison:
Not applicable.

3. Clinical studies:

a. Clinical Sensitivity:
Not applicable.

b. Clinical specificity:
Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.

4. Clinical cut-off:
Not applicable.

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5. Expected values/Reference range:
The expected values are provided in the labeling for each lot.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K070144](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K070144)

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